CN1459291A - Eyedrops containing low molecular weight heparin, and its prepn. method - Google Patents
Eyedrops containing low molecular weight heparin, and its prepn. method Download PDFInfo
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- CN1459291A CN1459291A CN 03112288 CN03112288A CN1459291A CN 1459291 A CN1459291 A CN 1459291A CN 03112288 CN03112288 CN 03112288 CN 03112288 A CN03112288 A CN 03112288A CN 1459291 A CN1459291 A CN 1459291A
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Abstract
An eyedrop for preventing and treating bacterial or chronic or allergic conjunctivitis, acquired cataract, pigmentary degeneration of retina, etc. features that its main active component is low-molecular heparin. If other active components are also contained, it can also be used to treating other ophthalmopathies. Its advantages are high curative effect, high biologic compatibility, and high safety.
Description
The invention belongs to field of pharmaceutical technology, is a kind of eye drop that contains Low molecular heparin that is mainly used in prevention and some ophthalmic diseasess such as treatment bacterial conjunctivitis, chronic conjunctivitis, anaphylaxis conjunctivitis, retinitis pigmentosa, degeneration of macula, bulbar conjunctiva bleed bottom and conjunctival congestion.
Chronic conjunctivitis is common a kind of ophthalmic diseases, mainly is owing to an eye table cell is subjected to physics or the chemical stimulation reaction that is inflamed, and discharges the inflammatory material, causes histiocyte to damage and visual deterioration.Anaphylaxis conjunctivitis is a kind of seasonal allergic conjunctivitis, state of an illness Chang Fanfu outbreak.Present used medicine mainly is adrenocortical hormone and NSAID (non-steroidal anti-inflammatory drug), and their regular meeting causes that intraocular pressure raises, and life-time service can cause glaucoma or cataract.
Low molecular heparin has antiinflammatory action, can suppress the activation of immunostimulation or the inductive mastocyte of non-immunostimulation, suppresses it and discharges the inflammatory material.Therefore, they can be used for treating chronic conjunctivitis and anaphylaxis conjunctivitis.In addition, Low molecular heparin also can suppress the absorption of antibacterial on the eye surface, can be used for the prevention of acute bacterial conjunctivitis.Compare with NSAID (non-steroidal anti-inflammatory drug) with adrenocortical hormone, Low molecular heparin has good biocompatibility, does not cause advantages such as intraocular pressure rising and life-time service safety, is a kind of comparatively ideal medicine.
Cataract also is the common ophthalmic diseases of losing one's sight of easily causing, and mainly treats by operation at present.Can cause after cataract and serious inflammation behind outer extraction of cataract capsule and the implantation of artificial lens, cause visual deterioration, corneal edema finally causes losing one's sight.This mainly is because the residual lens epithelial cells of postoperative is converted into fibroblast, and a large amount of hypertrophy and back, edge capsule are divided a word with a hyphen at the end of a line, and it is muddy that posterior lens capsule is taken place, and forms after cataract, and the while also can be caused inflammation.Present employed adrenocortical hormone and NSAID (non-steroidal anti-inflammatory drug) raise the secondary glaucoma in the antiphlogistic intraocular pressure that can cause simultaneously.Low molecular heparin can suppress epithelial hypertrophy and fibrinous oozing out, thereby effectively stops the generation of after cataract.
Retinitis pigmentosa is the ophthalmic diseases of carrying out property of a class visual function damage, often show as look wax yellow, the little blood vessel of nipple attenuates and the ambitus near osteocyte sample mottle calmness, and cause and finally cause decline, nyctalopia and the constriction of visual field of chromatic discrimination power losing one's sight.This is mainly by retinal cell function of eyes decline and form pigment and coagulate speckle and cause.Degeneration of macula also is a kind of common person in middle and old age's fundus oculi disease, is a kind of pathological changes of optical fundus macula retinae portion, can cause that vision slowly descends, and finally causes losing one's sight.Cause under main and retinal pigment epithelium deterioration and the choroidal artery intrusion retina ooze out, hemorrhage and proliferation of fibrous tissue is relevant.At present, retinitis pigmentosa and degeneration of macula all do not have prevention or cure method preferably.Low molecular heparin has anti thrombotic action, can improve the blood capillary circulation, suppresses pigmentation, also can suppress the retinal epithelium cell and transform to thrombin to fibroblastic conversion and thrombinogen, thereby suppress oozing out of tissue fibrin.Therefore, Low molecular heparin can be used for the prevention and the treatment of retinitis pigmentosa and degeneration of macula.
The bulbar conjunctiva bleed bottom mainly shows as white of the eye position and ecchymosis occurs, and is hemorrhage inboard from palpebral fissure, spreads to whole white of the eye position then.Common cause has excess eye-using and blood vessel elasticity difference etc., and is relevant with long-term violent cough, inflammation, wound, hypertension, arteriosclerosis etc. in addition.Low molecular heparin can suppress capillary permeability, reduces blood viscosity, thereby can prevent and treat bulbar conjunctiva bleed bottom and conjunctival congestion.
The purpose of this invention is to provide a kind of eye drop that contains Low molecular heparin that is mainly used in prevention and some ophthalmic diseasess such as treatment bacterial conjunctivitis, chronic conjunctivitis, anaphylaxis conjunctivitis, retinitis pigmentosa, degeneration of macula, bulbar conjunctiva bleed bottom and conjunctival congestion.Compare the present invention with the other treatment medicine and have good biocompatibility, do not cause that intraocular pressure raises and advantages such as life-time service safety.
The basic comprising of eye drop of the present invention is heparin sodium or clarin or their mixture, conventional eye with adjuvant and purified water, and wherein conventional eye comprises pH regulator agent, osmotic pressure regulator, antioxidant and antibacterial etc. with adjuvant.Above basic comprising can be mixed with eye drop of the present invention.
Also can on above-mentioned basic comprising basis, add other pharmacological active substancies as required, as antibiotics, antiviral agents, adrenocortical hormone, antifungal agent, synthetic antimicrobial drug, antiallergic agent, miotic, remission medicine and promotion wound healing medicine etc.Antibiotics comprises gentamycin sulfate, lincomycin, rifampicin etc.; Antiviral agents comprises acyclovir, ribavirin etc.; Adrenocortical hormone comprises dexamethasone sodium phosphate, hydrocortisone etc.; Antifungal agent comprises fluconazol etc.; Synthetic antimicrobial drug comprises norfloxacin, ofloxacin, ciprofloxacin, lomefloxacin etc.; Antiallergic agent comprises sodium cromoglicate etc.; Miotic comprises pilocarpine nitrate etc.; The remission medicated bag is drawn together zinc sulfate, oxymetazoline, carteolol hydrochloride etc.; Promote the wound healing medicated bag to draw together glass acid and salt, allantoin, chitosan and salt, chondroitin sulfate etc.
The prescription and the amount ranges of eye drop of the present invention are: in 100 milliliters of eye drops, and the anti-FXa of Low molecular heparin 1 000～600 000 units of tiring wherein, hyaluronic acid sodium 0～0.5 gram, conventional eye is used right amount of auxiliary materials, and all the other are purified water.Wherein hyaluronic acid sodium can be replaced in right amount by other one or more pharmacological components, and eye with adjuvant can for: phosphoric acid buffer to or borate buffer to or hydrochloric acid or sodium hydroxide solution in right amount to regulate pH5.0～9.0, osmotic pressure regulator sodium chloride 0～0.9 gram or glycerol 0～3.5 gram, antibacterial benzalkonium bromide or benzalkonium chloride or 0～0.02 gram such as acetomeroctol or ethyl hydroxybenzoate, 0～1.0 gram such as antioxidant sodium sulfite or vitamin E or antioxidation synergist disodiumedetate, etc.
The preparation method of eye drop of the present invention is as follows: prescription and consumption by eye drop of the present invention, hyaluronic acid sodium is immersed in an amount of purified water, and make its dissolving back standby; Get buffering, antibacterial, antioxidant etc. are added an amount of purified water dissolving, but heating for dissolving in case of necessity, add the Low molecular heparin dissolving again, fat-soluble antioxidant and antibacterial can join in the aqueous solution of Low molecular heparin more earlier with a small amount of dehydrated alcohol and tween dissolving, add hyaluronic acid sodium solution again, add purified water to volume, stir, transfer pH 5.0～9.0 with hydrochloric acid or sodium hydroxide solution, 0.22 the filtering with microporous membrane degerming of μ m promptly gets eye drop of the present invention after the packing.
The specific embodiment of the invention: 1 gets glycerol 2.6 grams, Borax 0.04 gram, disodiumedetate 0.04 gram, acetomeroctol 0.002 gram adds an amount of purified water dissolving, add low molecular sodium heparin 4 000 units, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, 0.22 the filtering with microporous membrane degerming of μ m, after the packing promptly.2 get sodium chloride 0.85 gram, Borax 0.04 gram, ethyl hydroxybenzoate 0.002 gram, sodium sulfite 0.02 gram adds an amount of purified water dissolving, add the dissolving of low molecular sodium heparin 12 000 units, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, 0.22 the filtering with microporous membrane degerming of μ m, after the packing promptly.3 get glycerol 2.4 grams, Borax 0.04 gram, and acetomeroctol 0.002 gram adds an amount of purified water dissolving, and the dissolving of adding low molecular sodium heparin 20 000 units is standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join again in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, with the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.4 get lincomycin 0.25 gram, glycerol 2.5 grams, and Borax 0.01 gram adds an amount of purified water dissolving, and the dissolving of adding low molecular sodium heparin 3 000 units is standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.5 get acyclovir 0.01 gram, and sodium chloride 0.88 restrains, Borax 0.04 gram, and ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 2 000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.6 get dexamethasone sodium phosphate 0.1 gram, and sodium chloride 0.85 restrains, Borax 0.04 gram, and ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 3 000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.7 get levofloxacin 0.3 gram, sodium chloride 0.88 gram, and Borax 0.04 gram adds an amount of purified water dissolving, and the dissolving of adding low molecular sodium heparin 3 000 units is standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.8 get sodium cromoglicate 2.0 grams, and sodium chloride 0.88 restrains, Borax 0.04 gram, and ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 3 000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.9 get pilocarpine nitrate 0.5 gram, and sodium chloride 0.88 restrains, Borax 0.04 gram, and ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 3 000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide, the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.10 get zinc sulfate 0.2 gram, and sodium chloride 0.88 restrains, Borax 0.04 gram, and ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 3 000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the aqueous solution, replenish purified water to 100 milliliter, stir, transfer about pH to 7.0 with hydrochloric acid or sodium hydroxide solution, 0.22 the filtering with microporous membrane degerming of μ m, after the packing promptly.11 get hyaluronic acid sodium 0.1 gram, and to add suitable quantity of water dissolving back standby; Get glycerol 2.5 grams, Borax 0.04 gram, ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, and the dissolving of adding low molecular sodium heparin 3000 units is standby; Get vitamin E 0.1 gram, add anhydrous
0.2 milliliter of ethanol and tween 80 0.1 gram dissolving join in the Low molecular heparin sodium water solution, and the adding hyaluronic acid sodium are molten
Liquid replenishes purified water to 100 milliliter, stirs, and hydrochloric acid or sodium hydroxide solution are transferred about pH to 7.0, with 0.22
The filtering with microporous membrane degerming of μ m, after the packing promptly.The human body clinical trial of eye drop of the present invention:
Test prepares with eye drop: getting hyaluronic acid sodium 0.1 gram, to add suitable quantity of water dissolving back standby; Get sodium chloride 0.85 gram and restrain, Borax 0.04 gram, ethyl hydroxybenzoate 0.002 gram adds an amount of purified water dissolving, adds low molecular sodium heparin 20000 units and dissolves standby; Get vitamin E 0.1 gram, add 0.2 milliliter of dehydrated alcohol and tween 80 0.1 gram dissolving, join in the Low molecular heparin sodium water solution, and add hyaluronic acid sodium solution, and replenish purified water to 100 milliliter, stir, with the filtering with microporous membrane degerming of 0.22 μ m, after the packing promptly.
Subjects: chronic conjunctivitis 19 examples (38), wherein male 8 examples (16), women 11 examples (22).
Administration: drip with test and use the low molecular sodium heparin eye drop, 4 times on the one, one time 1, continuous use January, observe the curative effect and intraocular pressure variation.
Result: administration January, cure 28,10 of produce effects, invalid 0.Do not see hemorrhage and intraocular pressure rising phenomenon.
The result shows that the low molecular sodium heparin eye drop can effectively treat conjunctivitis and have no adverse reaction.
Claims (7)
1 one kinds of eye drops that contain Low molecular heparin is characterized in that containing Low molecular heparin.
2 one kinds of eye drops that contain Low molecular heparin as claimed in claim 1 is characterized in that the basic comprising of filling a prescription is Low molecular heparin, conventional eye medicine adjuvant and purified water.
3 one kinds of eye drops that contain Low molecular heparin as claimed in claim 1, Low molecular heparin in it is characterized in that filling a prescription is meant sodium, potassium, calcium and other salt or their mixture of Low molecular heparin, and consumption is tire 1000～600 000 unit/100 milliliter of anti-FXa.
4 one kinds of eye drops that contain Low molecular heparin as claimed in claim 2, eye medicine adjuvant in it is characterized in that filling a prescription comprises: phosphoric acid buffer to or borate buffer to or hydrochloric acid or sodium hydroxide solution to regulate pH5.0～9.0, osmotic pressure regulator sodium chloride 0～0.9 gram or glycerol 0～3.5 gram, antiseptic benzalkonium bromide or benzalkonium chloride or acetomeroctol or ethyl hydroxybenzoate 0～0.2 gram, antioxidant sodium sulfite or vitamin E or antioxidation synergist disodiumedetate 0～1.0 gram.
5 one kinds of eye drops that contain Low molecular heparin as claimed in claim 2, also can add other pharmacological components in it is characterized in that filling a prescription as required, comprise antibiotics, antiviral agents, adrenocortical hormone, antifungal agent, synthetic antibacterial drug, antiallergic agent, miotic, remission medicine, promote the wound healing medicine.
6 one kinds of eye drops that contain Low molecular heparin as claimed in claim 5 is characterized in that antibiotics is meant gentamycin sulfate, lincomycin, rifampicin; Antiviral agents is meant acyclovir, ribavirin; Adrenocortical hormone is meant dexamethasone sodium phosphate, hydrocortisone; Antifungal agent is meant fluconazol; Synthetic antimicrobial drug is meant norfloxacin, ofloxacin, ciprofloxacin, lomefloxacin; Antiallergic agent is meant sodium cromoglicate; Miotic is meant pilocarpine nitrate; The remission medicine is meant zinc sulfate, oxymetazoline, carteolol hydrochloride; Promote the wound healing medicine to be meant glass acid and salt, allantoin, chitosan and salt thereof, chondroitin sulfate.
7 one kinds as the described eye drop that contains Low molecular heparin of claim 1 to 6, it is characterized in that preparation method is as follows: by the prescription and the consumption of eye drop of the present invention, hyaluronic acid sodium is immersed in an amount of purified water, make its dissolving back standby, it is right to get buffering, antibacterial, antioxidants etc. add an amount of purified water dissolving, but heating for dissolving in case of necessity, add Low molecular heparin again, fat-soluble antioxidant and antibacterial can be earlier with joining in the Low molecular heparin aqueous solution after a small amount of dehydrated alcohol and the tween dissolving again, add hyaluronic acid sodium solution again, add purified water, stir, transfer pH 5.0～9.0 with hydrochloric acid or sodium hydroxide solution, the filtering with microporous membrane degerming of 0.22 μ m promptly gets eye drop of the present invention after the packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03112288 CN1459291A (en) | 2003-05-28 | 2003-05-28 | Eyedrops containing low molecular weight heparin, and its prepn. method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 03112288 CN1459291A (en) | 2003-05-28 | 2003-05-28 | Eyedrops containing low molecular weight heparin, and its prepn. method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670493A (en) * | 2012-05-22 | 2012-09-19 | 宁夏康亚药业有限公司 | Lomefloxacin hydrochloride eye drops and preparation method and application thereof |
| CN102670494A (en) * | 2012-05-22 | 2012-09-19 | 宁夏康亚药业有限公司 | Eye drop and preparation method and application thereof |
| CN106267151A (en) * | 2016-08-22 | 2017-01-04 | 高伟荣 | Irrigation of lacrimal passage liquid is used in a kind of children's's dacryocystisis nursing |
| JP2020525416A (en) * | 2017-06-29 | 2020-08-27 | アドヴァイテ エルエルシー． | Treatment and diagnosis of ocular surface disorders |
-
2003
- 2003-05-28 CN CN 03112288 patent/CN1459291A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670493A (en) * | 2012-05-22 | 2012-09-19 | 宁夏康亚药业有限公司 | Lomefloxacin hydrochloride eye drops and preparation method and application thereof |
| CN102670494A (en) * | 2012-05-22 | 2012-09-19 | 宁夏康亚药业有限公司 | Eye drop and preparation method and application thereof |
| CN102670493B (en) * | 2012-05-22 | 2013-09-18 | 宁夏康亚药业有限公司 | Lomefloxacin hydrochloride eye drops and preparation method and application thereof |
| CN106267151A (en) * | 2016-08-22 | 2017-01-04 | 高伟荣 | Irrigation of lacrimal passage liquid is used in a kind of children's's dacryocystisis nursing |
| JP2020525416A (en) * | 2017-06-29 | 2020-08-27 | アドヴァイテ エルエルシー． | Treatment and diagnosis of ocular surface disorders |
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