CN1183302A - Eye drops contg. sodium hyaluronate and preparing method thereof - Google Patents
Eye drops contg. sodium hyaluronate and preparing method thereof Download PDFInfo
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- CN1183302A CN1183302A CN 96116072 CN96116072A CN1183302A CN 1183302 A CN1183302 A CN 1183302A CN 96116072 CN96116072 CN 96116072 CN 96116072 A CN96116072 A CN 96116072A CN 1183302 A CN1183302 A CN 1183302A
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- eye drop
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Abstract
The eye drops for treating xeroma, conjunctivitis, keratitis and keratohelcosis with high curative effect contains such active components as sodium hyaluronate, glucerine, complexon III, phosphoric acid buffer pair or boric acid buffer pair or hydrochloric acid or sodium hydroxide for regulating pH value to 5.0-7.5, sodium chloride for regulating osmotic pressure, antiseptic and distilled water.
Description
The invention belongs to field of pharmaceutical technology, is a kind of main treatment xerophthalmia, also can treat the eye drop of various oculopathy such as various conjunctivitis, keratitis, corneal ulcer.Xerophthalmia is a kind of climacteric patient and common complaint among the elderly, and infant is because monophagia causes vitamin A deficiency also xerophthalmia can occur.Xerophthalmia is the disease that causes because of tear, mucin secretion deficiency, and Most patients easily causes various oculopathy such as xerophthalmia keratitis and conjunctivitis, causes many miseries to the patient.At present, China's medical market does not have the medicine of specially controlling xerophthalmia as yet, generally only adopts oral medicines such as vitamin A, vitamin D to nurse one's health clinically, does not finally still reach the effect of treatment.And hyaluronic acid sodium (English: SodiumHyaluronate also claims hyaluronate sodium) has extremely strong moisture retention and lubricity, and external clinical data has proved the choice drug of this medicine for the treatment xerophthalmia.
In addition, treat the collyrium of oculopathy at present, owing to it can not rest in the eyelid long period, so therapeutic effect is not good enough.Though but the eye ointment long period rests in the eyelid,, block sight line, thereby be only limited to use in bed, bring inconvenience to the patient because of it is semi-solid thing.In the past, pharmaceutical industry improved the viscosity of medicinal liquid by the practice of adding thickening agent in eye drop, to reach was prolonged medicinal liquid time of staying in conjunctival sac, improved the purpose of drug effect, and the zest of eye drop is lowered.The customary thickeners of being added has methylcellulose, polyvinyl alcohol and polyvidon etc.Result of study in recent years shows that adopting natural mucopolysaccharide hyaluronic acid sodium is thickening agent, and the effect that is played is that above thickening agent is incomparable.Hyaluronic acid sodium is a macromolecule mucopolysaccharide that extracts in animal tissue or produce through bacterial fermentation, and by the regular macromole chain polysaccharide that repeats to constitute of disaccharide unit that D-glucuronic acid and N-acetylglucosamine ammonia constitute, molecular weight is 2.7～7.2 * 10
6Make it have unique character Deng the carboxyl on the glucuronic acid residue of space length, the most outstanding a bit is exactly the viscoelasticity that solution has height, and molecular weight is long more, and solution viscosity is high more.Be added to hyaluronic acid sodium in the eye drop and not only played the thickening effect of common thickening agent, and because the eye drop that hyaluronic acid sodium constituted is a non-Newtonian fluid, viscosity can descend rapidly with the increase of shearforce, thereby can not make the eye sensation difficult nictation, sticking slimy sensation is arranged, and this point be above-mentioned thickening agent institute inevitably.The more important thing is, external animal pharmacology and pharmacodynamics test studies show that, the animal corneal surface epithelial cell exists the hyaluronic acid sodium binding site, be after the eye drop of carrier enters ophthalmic with the hyaluronic acid sodium, combination by hyaluronic acid sodium and binding site, make medicinal liquid be stranded in the corneal epithelium surface for a long time, its effect that prolongs drug effect than with other thickening agent thickening, viscosity in addition up to the eye drop of tens of times of its viscosity can not reach.
Hyaluronic acid sodium is a macromolecular substances that chemical property is more stable, and is compatible with most drug, do not produce physical and chemical reaction.Existing many example proof hyaluronic acid sodiums can use with compatibilities such as most antibiotic, hormone, anti-inflammatory analgesics.
Purpose of the present invention: the eye drop that provides a kind of main treatment xerophthalmia, also can same antibiotic, hormone and other antimicrobial drug and remission medicine be made into compound preparation, constituting a series of is the eye drop series of carrier with the hyaluronic acid sodium, treat multiple oculopathy such as various conjunctivitis, keratitis, corneal ulcer, have that curative effect is strong, zest is little, and eye had extremely strong moistening and lubrication, the advantage of relief of symptoms simultaneously can be arranged; And provide the preparation method of this class eye drop.
The basic comprising of eye drop prescription of the present invention is: hyaluronic acid sodium, glycerol, phosphate-buffered to or the borate buffering to, phenylmercuric acetate and distilled water, wherein phenylmercuric acetate can substitute with other antiseptic commonly used.Itself can be mixed with eye drop this basic comprising, is used for the treatment of simple property xerophthalmia, can remove its symptom and play prevention because the Secondary cases inflammatory due to the xerophthalmia infects.
Also can on the basis of this basic comprising, add as required, as antibiotic, hormone, antimicrobial drug, antiviral agents, miotic and remission medicine as pharmacological active substance.All kinds of antibiotic of stabilized aqueous solutions such as antibiotics such as chloromycetin, gentamycin sulfate, polygynax, lincomycin, rifampicin; Antiviral agents is as acyclic uridnine (acyclovir) etc.; Glucocorticoids is as water solublity anti-inflammatory hormones such as dexamethasone sodium phosphates; Antimicrobial drug is as quinazolone classes such as norfloxacin, ofloxacin, ciprofloxacin, lomefloxacins; Cholinesterase inhibitor such as a miotic example hydrochloric acid Rocca product; The remission medicine is as beta receptor blockeres such as zinc sulfate, heparin and oxymetazolines; Short wound healing medicine is as allantoin, chondroitin sulfate etc.
The prescription and the amount ranges of eye drop of the present invention are: in 100 milliliters of eye drops, wherein hyaluronic acid sodium 0.05～0.5 restrains, glycerol 0～3.0 gram, disodiumedetate 0.01～0.5 gram, phosphoric acid buffer to or borate buffer to or hydrochloric acid or sodium hydroxide in right amount to regulate pH5.0～7.5, osmotic pressure regulator sodium chloride 0～0.9 gram, antiseptic 0.002～0.2, all the other are distilled water.In the time of need adding active ingredient, its consumption is according to officinal pertinent regulations.
Eye drop prescription of the present invention and consumption are: in the 100ml eye drop, and glycerol 2.6 grams, Borax 0.03 gram, hyaluronic acid sodium 0.05 gram, disodiumedetate 0.04 gram, benzalkonium bromide 0.004 gram, pH6.7 eye drop prescription of the present invention and consumption are: in the 100ml eye drop, chloromycetin 0.25 gram, glycerol 2.4 grams, Borax 0.01 gram, hyaluronic acid sodium 0.1 gram, disodiumedetate 0.02 gram, benzalkonium bromide 0.003 gram, pH6.5.
Eye drop prescription of the present invention and consumption are: in the 100ml eye drop, and acyclovir 0.01 gram, glycerol 2.6 grams, Borax 0.05 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.04 gram, phenylmercuric acetate 0.002 gram, pH7.6.
Eye drop prescription of the present invention and consumption are: in the 100ml eye drop, and gentamycin sulfate 500000 units, glycerol 2.2 grams, Borax 0.05 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.02 gram, phenylmercuric acetate 0.002 gram, pH6.3.
Eye drop prescription of the present invention and consumption are: in the 100ml eye drop, and polygynax 300 units, dexamethasone sodium phosphate 0.1 gram, Borax 0.5 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.3 gram, phenylmercuric acetate 0.002 gram, pH7.6.Eye drop prescription of the present invention and consumption are: in the 100ml eye drop, and chondroitin sulfate 3.0 grams, glycerol 2.6 grams, Borax 0.05 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.03 gram, phenylmercuric acetate 0.002 gram, pH7.6.
The manufacture method of eye drop of the present invention, prescription and consumption by eye drop of the present invention immerse hyaluronic acid sodium in the water, make its dissolving back standby.After getting heating for dissolving such as Borax, disodiumedetate, phenylmercuric acetate, glycerol, add active medicine again, if active ingredient to thermally labile, is adding in the time of solution can being chilled to lower temperature.When lysate is chilled to room temperature, add hyaluronic acid sodium solution, add distilled water then,, seal after the packing, promptly obtain eye drop of the present invention with the microporous filter membrane aseptic filtration of 0.2～0.5um to volume.
Since added hyaluronic acid sodium in the eye drop of the present invention, thus eye is had extremely strong moistening and lubrication, and can improve the nutrition of tissue, the obviously symptom of alleviating dry eye disease; The medicinal liquid adhesion is strong, and the surface activity height also can alleviate the stimulation of medicine to eye.Because eye drop of the present invention has certain viscosity, do not block sight line, but the long period rest in the conjunctival sac during use, and flow into nasal cavity not really soon, also be difficult for overflowing eyelid, increased area and time that medicinal liquid contacts with eye, so its raising evident in efficacy.Through clinic trial, treatment xerophthalmia effect is remarkable, and various diseases such as treatment trachoma, conjunctivitis, corneal ulcer, eyeball inflammation are all better than the curative effect of eye drop that does not add hyaluronic acid sodium and various eye ointment.
The embodiment of the invention:
1. eye drop of the present invention, in the 100ml eye drop, extracting chloromycetin 0.25 gram, glycerol 2.4 grams, Borax 0.01 gram, hyaluronic acid sodium 0.1 gram, disodiumedetate 0.02 gram, benzalkonium bromide 0.003 gram, all the other are distilled water, according to the method for the invention preparation, pH6.5.0.002 gram, all the other are distilled water, according to the method for the invention preparation, pH7.6.
3. eye drop of the present invention, in the 100ml eye drop, gentamycin sulfate 500000 units, glycerol 2.2 grams, Borax 0.05 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.02 gram, phenylmercuric acetate 0.002 gram, all the other are distilled water, according to the method for the invention preparation, pH6.3.
4. eye drop of the present invention, in the 100ml eye drop, polygynax 300 units, dexamethasone sodium phosphate 0.1 gram, Borax 0.5 gram, hyaluronic acid sodium 0.3 gram, disodiumedetate 0.3 gram, phenylmercuric acetate 0.002 gram, all the other are distilled water, according to the method for the invention preparation, pH7.6.
5. the preparation method of eye drop of the present invention: preparation 100ml eye drop, in advance 0.3 gram hyaluronic acid sodium is dissolved in the suitable quantity of water, make its dissolving standby.Take by weighing chondroitin sulfate 3.0 grams, glycerol 2.6 grams, Borax 0.05 gram, disodiumedetate 0.03 gram, phenylmercuric acetate 0.002 gram, after the heating for dissolving, solution is placed when being chilled to room temperature, add the good hyaluronic acid sodium solution of dissolving in advance, add distilled water behind the mix homogeneously to volume,, seal after the packing with the microporous filter membrane aseptic filtration of 0.2um, promptly obtain eye drop of the present invention, pH7.6.
6. the preparation method of eye drop of the present invention: preparation 100ml eye drop, in advance 0.1 gram hyaluronic acid sodium is dissolved in the suitable quantity of water, make its dissolving standby.Take by weighing chloromycetin 0.25 gram, glycerol 2.6 grams, Borax 0.02 gram, disodiumedetate 0.02 gram, bromo geramine 0.004 gram, after the heating for dissolving, solution is placed when being chilled to room temperature, add the good hyaluronic acid sodium solution of dissolving in advance, add distilled water behind the mix homogeneously to volume,, seal after the packing with the microporous filter membrane aseptic filtration of 0.2um, promptly obtain eye drop of the present invention, pH6.7.
7. the preparation method of eye drop of the present invention: preparation 100ml eye drop, in advance 0.1 gram hyaluronic acid sodium is dissolved in the suitable quantity of water, make its dissolving standby.Take by weighing acyclovir 0.01 gram, glycerol 2.6 grams, Borax 0.05 gram, disodiumedetate 0.04 gram, phenylmercuric acetate 0.002 gram is dissolved in the suitable quantity of water, and after the heating for dissolving, solution is placed when being chilled to room temperature, add the good hyaluronic acid sodium solution of dissolving in advance, add distilled water behind the mix homogeneously to volume,, seal after the packing with the microporous filter membrane aseptic filtration of 0.2um, promptly obtain eye drop of the present invention, pH7.6.
Claims (8)
1. one contains the eye drop that hyaluronic acid sodium is a Main Ingredients and Appearance, is used for the treatment of xerophthalmia.Also can contain other active substance in its prescription and constitute compound preparation, in this case, hyaluronic acid sodium as the carrier of these materials, is treated multiple oculopathy such as various conjunctivitis, keratitis, corneal ulcer in eye drop.Described active substance such as antibiotic, hormone, antimicrobial drug, antiviral agents, miotic and remission medicine.
2. according to claim 1 described eye drop, it is characterized in that containing hyaluronic acid sodium in the prescription, this hyaluronic acid sodium promptly extracts in the object automatically and to obtain, and also bacterial fermentation makes, and molecular weight ranges is 50～2,000,000 dalton.
3. according to claim 1 described eye drop, its feature also is to add osmotic pressure regulator in the prescription, this regulator promptly comprises electrolyteses such as conventional employed sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate, Borax, boric acid, also comprise non-electrolyte classes such as glycerol, glucose, consumption is according to conventional use amount.
4. according to claim 1 described eye drop, its feature also is also can add pharmaceutically-active ingredients as required, described active substance such as antibiotic, hormone, antimicrobial drug, antiviral agents, miotic and remission medicine in the prescription.All kinds of antibiotic of stabilized aqueous solutions such as antibiotics such as chloromycetin, gentamycin sulfate, polygynax, lincomycin, rifampicin; Antiviral agents is as acyclic uridnine (acyclovir) etc.; The steroid hormone class is as water solublity anti-inflammatory hormones such as dexamethasone sodium phosphates; Antimicrobial drug is as quinazolone classes such as norfloxacin, ofloxacin, ciprofloxacin, lomefloxacins; Cholinesterase inhibitor such as a miotic example hydrochloric acid Rocca product; The remission medicine is as beta receptor blockeres such as zinc sulfate, heparin and oxymetazolines; Short wound healing medicine is as allantoin, chondroitin sulfate etc.
5. according to claim 1 described eye drop, the buffer system that adds control pH during its feature also is to fill a prescription, as sodium hydrogen phosphate-sodium dihydrogen phosphate buffering to, boric acid-Borax buffering to, Borax-disodiumedetate buffering to and acid and alkali substances such as hydrochloric acid, sodium hydroxide or carbonate.
6. according to claim 1 described eye drop, during also being to fill a prescription, its feature adds the conventional antiseptic that uses, as: thimerosal, phenylmercuric nitrate, phenylmercuric acetate, bromo geramine, Metagin, second, third, butyl ester etc., its consumption is according to conventional use amount, is that every 100ml contains 0.001～0.3 gram and do not wait according to the antiseptic that is adopted.
7. the manufacture method of this serial eye drop is characterized in that: in advance hyaluronic acid sodium is immersed in an amount of distilled water, make its dissolving back standby.Other gets an amount of distilled water, dissolve required osmotic pressure regulator, pH controlling agent, antiseptic etc., add active ingredient then, this solution is put when being chilled to 0～40 ℃, add solvent hyaluronic acid sodium solution in advance, add distilled water behind the mix homogeneously to volume required,, seal after the packing with the microporous filter membrane aseptic filtration of 0.2～0.5um.
8. the manufacture method of this serial eye drop is characterized in that: produce the 100ml eye drop, 0.1 gram hyaluronic acid sodium is dissolved in about 20ml distilled water in advance.Take by weighing glycerol 2.6 grams, Borax 0.02 gram, disodiumedetate 0.02 gram, bromo geramine 0.004 gram, heating for dissolving is in about 60ml water, when treating that temperature is reduced to below 80 ℃, add 0.25 gram chloromycetin again, solution is placed when being chilled to room temperature, add the good hyaluronic acid sodium solution of dissolving in advance, add distilled water behind the mix homogeneously to volume,, seal after the packing with the microporous filter membrane aseptic filtration of 0.2um.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96116072A CN1086590C (en) | 1996-11-22 | 1996-11-22 | Eye drops contg. sodium hyaluronate and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96116072A CN1086590C (en) | 1996-11-22 | 1996-11-22 | Eye drops contg. sodium hyaluronate and preparing method thereof |
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| CN1183302A true CN1183302A (en) | 1998-06-03 |
| CN1086590C CN1086590C (en) | 2002-06-26 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN96116072A Expired - Lifetime CN1086590C (en) | 1996-11-22 | 1996-11-22 | Eye drops contg. sodium hyaluronate and preparing method thereof |
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| CN (1) | CN1086590C (en) |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1088553C (en) * | 1998-08-14 | 2002-08-07 | 凌沛学 | Disinfecting gel containing transparent sodium phytate and its preparing process |
| CN100348654C (en) * | 2003-02-27 | 2007-11-14 | 株式会社资生堂 | Medicinal composition for ophthal use containing acetylated hyaluronic acid |
| WO2010030725A1 (en) * | 2008-09-15 | 2010-03-18 | Bausch & Lomb Incorporated | Compositions comprising polymers having amino sugar units and methods of making and using same |
| CN101947309A (en) * | 2010-04-12 | 2011-01-19 | 南海朗肽制药有限公司 | Human basic fibroblast growth factor eye drops and preparation method thereof |
| CN1954855B (en) * | 2005-10-26 | 2012-01-04 | 信谊药厂 | Eye preparation containing sodium hyaluronate for treating fundus macular degeneration and its preparation method |
| CN102579492A (en) * | 2012-03-05 | 2012-07-18 | 兆科药业（广州）有限公司 | Sodium hyaluronate eyedrop containing deproteinized calf blood extractive and preparation method 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 |
| CN102727874A (en) * | 2012-07-18 | 2012-10-17 | 中国药科大学 | Recombinant hirudin eye drops and preparation method thereof |
| CN104906037A (en) * | 2015-06-23 | 2015-09-16 | 广西复鑫益生物科技有限公司平南分公司 | Recombinant hirudin eye drop and preparation method thereof |
| CN106265675A (en) * | 2016-08-29 | 2017-01-04 | 安徽艾珂尔制药有限公司 | A kind of antimicrobial form aciclovir eye drop and preparation method thereof |
| CN109528550A (en) * | 2018-12-27 | 2019-03-29 | 江苏海伦隐形眼镜有限公司 | A kind of dissolving method of sodium hyaluronate for solution preparation |
| CN110934823A (en) * | 2019-12-27 | 2020-03-31 | 湖北康源药业有限公司 | Valganciclovir hydrochloride oral solution and preparation method thereof |
| CN112870216A (en) * | 2021-01-29 | 2021-06-01 | 张宽才 | Pharmaceutical composition, preparation and application |
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| CN1302812C (en) * | 2004-11-30 | 2007-03-07 | 中国海洋大学 | Transmission system of medicine containing trehalose and hyaluronic acid for eye part and its preparation method |
| CN1923209B (en) * | 2005-09-02 | 2010-09-29 | 信谊药厂 | Phthiobuzonum eye drops containing sodium hyaluronate and its preparing process |
-
1996
- 1996-11-22 CN CN96116072A patent/CN1086590C/en not_active Expired - Lifetime
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1088553C (en) * | 1998-08-14 | 2002-08-07 | 凌沛学 | Disinfecting gel containing transparent sodium phytate and its preparing process |
| CN100348654C (en) * | 2003-02-27 | 2007-11-14 | 株式会社资生堂 | Medicinal composition for ophthal use containing acetylated hyaluronic acid |
| CN1954855B (en) * | 2005-10-26 | 2012-01-04 | 信谊药厂 | Eye preparation containing sodium hyaluronate for treating fundus macular degeneration and its preparation method |
| WO2010030725A1 (en) * | 2008-09-15 | 2010-03-18 | Bausch & Lomb Incorporated | Compositions comprising polymers having amino sugar units and methods of making and using same |
| CN101947309A (en) * | 2010-04-12 | 2011-01-19 | 南海朗肽制药有限公司 | Human basic fibroblast growth factor eye drops and preparation method thereof |
| CN101947309B (en) * | 2010-04-12 | 2012-09-19 | 南海朗肽制药有限公司 | Human basic fibroblast growth factor eye drops and preparation method thereof |
| CN102579492A (en) * | 2012-03-05 | 2012-07-18 | 兆科药业（广州）有限公司 | Sodium hyaluronate eyedrop containing deproteinized calf blood extractive and preparation method thereof |
| CN102670494B (en) * | 2012-05-22 | 2013-09-18 | 宁夏康亚药业有限公司 | Eye drop 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 |
| CN102727874A (en) * | 2012-07-18 | 2012-10-17 | 中国药科大学 | Recombinant hirudin eye drops and preparation method thereof |
| CN102727874B (en) * | 2012-07-18 | 2014-02-19 | 中国药科大学 | Recombinant hirudin eye drops and preparation method thereof |
| CN104906037A (en) * | 2015-06-23 | 2015-09-16 | 广西复鑫益生物科技有限公司平南分公司 | Recombinant hirudin eye drop and preparation method thereof |
| CN106265675A (en) * | 2016-08-29 | 2017-01-04 | 安徽艾珂尔制药有限公司 | A kind of antimicrobial form aciclovir eye drop and preparation method thereof |
| CN109528550A (en) * | 2018-12-27 | 2019-03-29 | 江苏海伦隐形眼镜有限公司 | A kind of dissolving method of sodium hyaluronate for solution preparation |
| CN110934823A (en) * | 2019-12-27 | 2020-03-31 | 湖北康源药业有限公司 | Valganciclovir hydrochloride oral solution and preparation method thereof |
| CN112870216A (en) * | 2021-01-29 | 2021-06-01 | 张宽才 | Pharmaceutical composition, preparation and application |
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|---|---|
| CN1086590C (en) | 2002-06-26 |
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