CN102579321A - Tinidazole ophthalmic gel, and preparation method and application thereof - Google Patents
Tinidazole ophthalmic gel, and preparation method and application thereof Download PDFInfo
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- CN102579321A CN102579321A CN2012100711432A CN201210071143A CN102579321A CN 102579321 A CN102579321 A CN 102579321A CN 2012100711432 A CN2012100711432 A CN 2012100711432A CN 201210071143 A CN201210071143 A CN 201210071143A CN 102579321 A CN102579321 A CN 102579321A
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Abstract
The invention relates to tinidazole ophthalmic gel, and a preparation method and application thereof, and belongs to the technical field of medicines. Tinidazole serving as a medicinal active ingredient is prepared into ophthalmic gel for the first time, and the tinidazole ophthalmic gel is applied to the prevention and treatment of blepharitis ciliaris, hordeolum and conjunctivitis which are infected by worm mites, xerophthalmia caused by meibomian gland dysfunction and acanthamoeba protozoa in the process of wearing corneal contact lenses and anaerobic infection. The tinidazole ophthalmic gel consists of the tinidazole and a medicinally-acceptable carrier, and on the basis of the weight of the tinidazole ophthalmic gel, the using amount of the tinidazole is 0.1 to 3.0 grams in each 100 grams of tinidazole ophthalmic gel.
Description
Technical field
The present invention relates to a kind of effective ingredient tinidazole, process the gel for eye use dosage form first, be applied to the application of eye anthelmintic demodicid mite, thorn ameba protozoon and anaerobic infection control.
Background technology
Intractable blepharitis, hordeolum, conjunctivitis and meibomian gland dysfunction (that research recently confirms is relevant with the anthelmintic mite infestationss for meibomain gland dysfunction, the xerophthalmia due to MGD) (international ophthalmology is scanned, and 2007,3:149; Clinical ophthalmology magazine, 2010,4:358).Mu Jian to 91 routine blepharitis patient anthelmintic demodicid mite recall rates 90% (clinical ophthalmology magazine, 2010,4:358).Gao to margo palpebrae portion anthelmintic demodicid mite recall rate 100% (Invest ophthalmol vis sci, 2005,46:3089).Acanthamoeba property keratitis is the serious blinding property oculopathy that infects owing to thorn ameba protozoon, and 75% has wearing of contact lens historical, can cause corneal ulcer even perforation of cornea.Tinidazole is to kill anthelmintic demodicid mite and the most effective unique medicine of thorn ameba protozoon, and the infection of car one-tenth industry application of self-made metronidazole eye drop prevention corneal contact lens thorn ameba protozoon (the Shandong medical journal, 2008,3:246).The conjunctival sac time of staying of common metronidazole eye drop is short, curative effect is low.The ophthalmic preparation of present domestic listing, also not seeing has the ophthalmic preparation of killing anthelmintic demodicid mite and thorn ameba protozoon, does not still have the report of the research and the pharmaceutical production of tinidazole gel for eye use.
Summary of the invention
There is not the technological deficiency that the eye medicinal preparation of killing anthelmintic demodicid mite and thorn ameba protozoon is arranged in the prior art in order to overcome.The purpose of this invention is to provide a kind of eye medicinal preparation of killing anthelmintic demodicid mite and thorn ameba protozoon infection; Specifically provide a kind of tinidazole gel for eye use; More particularly; Provide the gel for eye use of xerophthalmia due to blepharitis, hordeolum, conjunctivitis and the meibomian gland dysfunction of a kind of prophylactic treatment anthelmintic mite infestationss, the gel for eye use that thorn ameba protozoon infects in a kind of prophylactic treatment wearing of contact lens process is provided.Another object of the present invention is the method for preparing and the application of tinidazole gel for eye use in preparation prophylactic treatment eye part disease medicine of tinidazole gel for eye use.
In order to realize above-mentioned goal of the invention, technical scheme of the present invention is:
The tinidazole gel for eye use is the single preparations of ephedrine of tinidazole, according to preparation title and the corresponding to principle of raw material, and these article called after tinidazole gel for eye use, English is called: Tinidazole Ophthalmic Gel.Gel for eye use is the opthalmological dosage form of State Food and Drug Administration's approval, and this gel for eye use dosage form (Ophthalmic Gel) also is called gel-type eye ointment, gel-type eye drop, gel type eye drop.
This tinidazole gel for eye use; It contains the medicine activity component tinidazole and the medicine acceptable carrier is formed; The tinidazole consumption is 0.1～3.0g in every by weight 100g tinidazole gel for eye use; The tinidazole preferable amount is 0.5～1.5g in every by weight 100g tinidazole gel for eye use, in every by weight 100g tinidazole gel for eye use tinidazole more preferably consumption be 0.75g.This tinidazole gel for eye use contains tinidazole 0.1～3.0g, card pool nurse 0.1～10.0g, hydroxypropyl methylcellulose 0.04～20.0g, the rigid Oleum Ricini 0.01～5.0g of hydrogenation, boric acid 0.3～3.0g, propylene glycol 0.1～5.0g, sodium chloride 0.5～1.0g, ethyl hydroxybenzoate 0.01～0.05g in every by weight 100g tinidazole gel for eye use.This tinidazole gel for eye use, preferable amount: contain tinidazole 0.75g, card pool nurse 0.8g, hydroxypropyl methylcellulose 0.2g, the rigid Oleum Ricini 1.0g of hydrogenation, boric acid 1.0g, propylene glycol 1.0g, sodium chloride 0.5g, ethyl hydroxybenzoate 0.025g in every 100g tinidazole gel for eye use.
This tinidazole gel for eye use Chinese medicine acceptable carrier also refers to the medicine acceptable auxiliary.The medicine acceptable carrier is one or more in gel-type vehicle, isoosmotic adjusting agent, PH regulator, water for injection, the antiseptic.In preparation tinidazole gel for eye use process, preferably select the stable good and less medicine acceptable carrier of zest.Gel-type vehicle is one or more in card pool nurse, the rigid Oleum Ricini of hydrogenation, dextran, glycerol, poloxamer, tween, hyaluronic acid sodium, methylcellulose, hydroxy methocel, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, the polyvinylpyrrolidone; The gel-type vehicle consumption is 0.1～40.0% in the gel for eye use, preference card pool nurse, the rigid Oleum Ricini of hydrogenation, hyaluronic acid sodium, hydroxypropyl methylcellulose.Isoosmotic adjusting agent is one or more in glycerol, propylene glycol, glycerin, sodium chloride, glucose, mannitol, the sorbitol, and the isoosmotic adjusting agent consumption is 0～8.0% in the gel for eye use, preferred propylene glycol, sodium chloride.The PH regulator is one or more in boric acid, Borax, glacial acetic acid, hydrochloric acid, sodium hydroxide, triethanolamine, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium hydrogen phosphate, sodium dihydrogen phosphate, the phosphoric acid; Gel for eye use PH is adjusted between 4.0 to 9.0 preferred boric acid, Borax, sodium hydroxide with the PH regulator.Antiseptic is one or more in chlorocresol, nipalgin, methyl hydroxybenzoate, propylparaben, chlorobutanol, phenoxyethanol, chlorhexidine, oradol, benzalkonium chloride, benzalkonium bromide, the ethyl hydroxybenzoate; The antiseptic consumption is 0～0.2% in the gel for eye use, preferred nipalgin, chlorobutanol, ethyl hydroxybenzoate.
The method for preparing of tinidazole gel for eye use of the present invention: tinidazole is dissolved with an amount of water for injection; Stir with hydroxypropyl methylcellulose, the rigid Oleum Ricini of hydrogenation, propylene glycol, sodium chloride, boric acid, ethyl hydroxybenzoate respectively; Heating is dissolved it fully, forms tinidazole solution; To block the pool nurse and be spread in the water for injection, be swelled into gel solution, add above-mentioned tinidazole solution, pressure sterilizing, cooling, filtration, packing, packing promptly get.
Tinidazole gel for eye use of the present invention still is a kind of invention of clinical ophthalmology purposes, also is the application of tinidazole gel for eye use in preparation control eye part disease medicine, and the tinidazole consumption is 0.1～3.0g in every by weight 100g tinidazole gel for eye use.
The pharmacological action of tinidazole gel for eye use of the present invention and clinical treatment mechanism are following:
Vermiform mite (Demodex) is a kind of small-sized permanent parasitic mite, and what parasitize human body has hair follicle anthelmintic demodicid mite and a sebum anthelmintic demodicid mite, and in a single day human body infects the anthelmintic demodicid mite, without killing anthelmintic demodicid mite Drug therapy, will not heal all the life.Eyelid is rich in fine and close eyelashes capsule and enriches sebaceous gland and tarsal glands; It is the easy infection position of anthelmintic demodicid mite; In case anthelmintic mite infestationss eyelashes capsule, eyelashes sebaceous gland and tarsal glands will cause that xerophthalmia takes place due to blepharitis, hordeolum, conjunctivitis and the tarsal glands functional disorder.At present on the opthalmological market, do not have the ophthalmic preparation of killing the anthelmintic demodicid mite arranged, cause anthelmintic mite infestationss property eye inflammation prolongedly do not heal, obstinate stored for a long time.
Acanthamoeba property keratitis is a kind of serious blinding property oculopathy, is by due to thorn ameba protozoon (Acanthamoeba) infection of type free life.Bibliographical information is arranged, and 52～88.9% Acanthamoeba property keratitis betide in the wearing of contact lens process, because due to contact lens, conditioning liquid, tap water and mirror case etc. are polluted by thorn ameba protozoon.Owing on the opthalmological market, do not have and kill the thorn ameba protozoon ophthalmic preparation, cause the sickness rate of Acanthamoeba property keratitis to increase year by year, part patient even cause blindly.
Tinidazole belongs to the nitro glyoxaline synthetic antibacterial drug, English name Metronidazole.Tinidazole has the unique effect of killing anthelmintic demodicid mite, thorn ameba protozoon and wide spectrum anaerobe resistant, is the choice drug of the above-mentioned eye infected by microbes of prophylactic treatment.
The present invention selects to have the strong tinidazole of effectively killing anthelmintic demodicid mite and thorn ameba protozoon infection as medicine activity component; Select the medicine acceptable carrier; Be prepared into eye-gel preparation through modern eye-gel preparation technology, be used for application at preparation prophylactic treatment eye part disease medicine.
Good effect of the present invention: the present invention has filled up the blank of domestic ophthalmic remedy, and specifically: having filled up not have in the tinidazole medicine to have does not have the blank that the tinidazole medicine is arranged in gel for eye use dosage form and the gel for eye use dosage form.More positive effect is, filled up the ophthalmic preparation of the xerophthalmia due to blepharitis, hordeolum, conjunctivitis and the meibomian gland dysfunction of prophylactic treatment eye anthelmintic mite infestationss; Fill up the ophthalmic preparation of the Acanthamoeba property keratitis due to the prophylactic treatment thorn ameba protozoon infects, particularly provide wearing of contact lens person to prevent the application in the thorn ameba protozoon infection medicine.The tinidazole gel for eye use has unrivaled advantage with respect to ordinary eye drops and common eye ointment dosage form, and gel for eye use time of staying in conjunctival sac is long, is easy to drug absorption, and clear gel does not cause blurred vision, all can use round the clock.Xerophthalmia due to blepharitis, hordeolum, conjunctivitis and the meibomian gland dysfunction is the most common oculopathy of ophthalmology, and wearing of contact lens person has 400,000,000 crowds approximately, and the tinidazole gel for eye use of this invention has very big society and economy benefit.The present invention produces outstanding substantial variation, has outstanding substantive distinguishing features and obvious improvement.
Tinidazole gel for eye use of the present invention through lagophthalmos repeatedly the local irritation experimentation of coating show these article nonirritant; Medicine is stablized experimentation and shown, and is more stable under these article room temperature.The tinidazole gel for eye use, through the clinical efficacy test evaluation, the effective xerophthalmia due to prophylactic treatment blepharitis, hordeolum, conjunctivitis and the meibomian gland dysfunction.
The specific embodiment
Through following embodiment, can understand the excellent effect that inventive concept of the present invention and invention obtain better.The embodiment that is provided just in order to help to understand the present invention, rather than constitutes the invention protection domain is played restriction, under design prerequisite of the present invention, the present invention is simply changed, and all belongs to the scope of requirement protection of the present invention.
Embodiment 1:
Prescription is formed: tinidazole 0.75g, card pool nurse 0.8g, hydroxypropyl methylcellulose 0.2g, the rigid Oleum Ricini 1.0g of hydrogenation, boric acid 1.0g, propylene glycol 1.0g, sodium chloride 0.5g, ethyl hydroxybenzoate 0.025g; Water for injection adds to full dose, processes 100g tinidazole gel for eye use.
Method for preparing: tinidazole is dissolved with an amount of water for injection, stir with hydroxypropyl methylcellulose, the rigid Oleum Ricini of hydrogenation, boric acid, propylene glycol, sodium chloride, ethyl hydroxybenzoate respectively, heating is dissolved it fully, forms tinidazole solution; To block the pool nurse and be spread in the water for injection, be swelled into gel solution, add above-mentioned tinidazole solution, pressure sterilizing, cooling, filtration, packing, packing promptly get.
Embodiment 2:
Prescription is formed: tinidazole 0.5g, card pool nurse 0.8g, hydroxypropyl methylcellulose 0.2g, the rigid Oleum Ricini 1.0g of hydrogenation, boric acid 1.0g, propylene glycol 1.0g, sodium chloride 0.5g, ethyl hydroxybenzoate 0.025g; Water for injection adds to full dose, processes 100g tinidazole gel for eye use.
Method for preparing: with embodiment 1.
Embodiment 3:
Prescription is formed: tinidazole 1.0g, card pool nurse 0.8g, hydroxypropyl methylcellulose 0.2g, the rigid Oleum Ricini 1.0g of hydrogenation, boric acid 1.0g, propylene glycol 1.0g, sodium chloride 0.5g, ethyl hydroxybenzoate 0.025g; Water for injection adds to full dose, processes 100g tinidazole gel for eye use.
Method for preparing: with embodiment 1.
Embodiment 4:
Prescription is formed: tinidazole 0.1～3.0g, card pool nurse 0.1～10.0g, hydroxypropyl methylcellulose 0.04～20.0g, the rigid Oleum Ricini 0.01～5.0g of hydrogenation, boric acid 0.3～3.0g, propylene glycol 0.1～5.0g, sodium chloride 0.5～1.0g, ethyl hydroxybenzoate 0.01～0.05g; Water for injection adds to full dose, processes 100g tinidazole gel for eye use.
Method for preparing: with embodiment 1.
Embodiment 5: tinidazole gel for eye use lagophthalmos irritant test
Get 4 of test rabbits, right eye is as the test eye, and left eye is as the contrast eye, and right eye drips 0.75% tinidazole gel for eye use, splashes into 1 at every turn, and every day, eye drip was 4 times, and eye drip is 7 days continuously.Through naked eyes and slit lamp examination, observe conjunctiva, cornea and iris IR situation.Drip the experimental eye of tinidazole gel for eye use, with left eye contrast eye, eyes all do not have any IR.
Embodiment 6: the clinical trial therapeutic evaluation
Case is selected: select the wearing of contact lens patient, amount to 26 eyes, use 0.75% tinidazole gel for eye use of preparation, be coated with for 4 times every day and wear eye, continuous use 14 days is observed eye conjunctiva and cornea situation.Any discomfort symptom and conjunctiva anomaly of cornea sign do not take place in the Total Test case.
Embodiment 7: the clinical trial therapeutic evaluation
Case is selected: the diagnostic criteria of anthelmintic mite infestationss property oculopathy, and one is the clinical xerophthalmia due to blepharitis, hordeolum, conjunctivitis and the tarsal glands functional disorder that meets, inspection finds that margo palpebrae is congested, the conjunctival congestion sign; Another is that anthelmintic demodicid mite microscopy is positive: clinical diagnosis patient's eyelid eyelashes are pulled out 4, eyelashes are placed on the microscope slide, on microscope slide, drip normal saline, cover microscope slide, microscopically counting anthelmintic demodicid mite, it is positive to detect anthelmintic demodicid mite person.Meet clinical diagnosis and eyelashes anthelmintic demodicid mite microscopy positive person, amount to 18 eyes.Use 0.75% tinidazole gel for eye use of preparation, be coated with for 4 times every day and suffer from eye, treat 21 days continuously after, observe eye symptom, sign and eyelashes anthelmintic demodicid mite microscopy result.Suffer from an eye symptom, sign disappears and eyelashes anthelmintic demodicid mite microscopy negative patient, is judged as treatment effectively.Tinidazole gel for eye use of the present invention, through the clinical experiment therapeutic evaluation, total effective rate is 92%.
Claims (10)
1. tinidazole gel for eye use is characterized in that: it contains the medicine activity component tinidazole and the medicine acceptable carrier is formed, and the tinidazole consumption is 0.1～3.0g in every by weight 100g tinidazole gel for eye use.
2. tinidazole gel for eye use according to claim 1 is characterized in that: the tinidazole consumption is 0.5～1.5g in every by weight 100g tinidazole gel for eye use.
3. tinidazole gel for eye use according to claim 1 is characterized in that: the tinidazole consumption is 0.75g in every by weight 100g tinidazole gel for eye use.
4. tinidazole gel for eye use according to claim 1 is characterized in that: contain tinidazole 0.1～3.0g, card pool nurse 0.1～10.0g, hydroxypropyl methylcellulose 0.04～20.0g, the rigid Oleum Ricini 0.01～5.0g of hydrogenation, boric acid 0.3～3.0g, propylene glycol 0.1～5.0g, sodium chloride 0.5～1.0g, ethyl hydroxybenzoate 0.01～0.05g in every by weight 100g tinidazole gel for eye use.
5. tinidazole gel for eye use according to claim 1 is characterized in that: contain tinidazole 0.75g, card pool nurse 0.8g, hydroxypropyl methylcellulose 0.2g, the rigid Oleum Ricini 1.0g of hydrogenation, boric acid 1.0g, propylene glycol 1.0g, sodium chloride 0.5g, ethyl hydroxybenzoate 0.025g in every 100g tinidazole gel for eye use.
6. tinidazole gel for eye use according to claim 1 is characterized in that: the medicine acceptable carrier is gel-type vehicle, isoosmotic adjusting agent, P
HIn regulator, water for injection, the antiseptic one or more.
7. tinidazole gel for eye use according to claim 6; It is characterized in that: gel-type vehicle is one or more in card pool nurse, the rigid Oleum Ricini of hydrogenation, dextran, glycerol, poloxamer, tween, hyaluronic acid sodium, methylcellulose, hydroxy methocel, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, the polyvinylpyrrolidone, and the gel-type vehicle consumption is 0.1～40.0% in the gel for eye use; Isoosmotic adjusting agent is one or more in glycerol, propylene glycol, glycerin, sodium chloride, glucose, mannitol, the sorbitol, and the isoosmotic adjusting agent consumption is 0～8.0% in the gel for eye use; P
HRegulator is one or more in boric acid, Borax, glacial acetic acid, hydrochloric acid, sodium hydroxide, triethanolamine, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium hydrogen phosphate, sodium dihydrogen phosphate, the phosphoric acid, uses P
HRegulator is with gel for eye use P
HBe adjusted between 4.0 to 9.0; Antiseptic is one or more in chlorocresol, nipalgin, methyl hydroxybenzoate, propylparaben, chlorobutanol, phenoxyethanol, chlorhexidine, oradol, benzalkonium chloride, benzalkonium bromide, the ethyl hydroxybenzoate, and the antiseptic consumption is 0～0.2% in the gel for eye use.
8. according to the method for preparing of claim 4 or 5 described tinidazole gel for eye use; It is characterized in that: tinidazole is dissolved with an amount of water for injection; Stir with hydroxypropyl methylcellulose, the rigid Oleum Ricini of hydrogenation, propylene glycol, sodium chloride, boric acid, ethyl hydroxybenzoate respectively; Heating is dissolved it fully, forms tinidazole solution; To block the pool nurse and be spread in the water for injection, be swelled into gel solution, add above-mentioned tinidazole solution, pressure sterilizing, cooling, filtration, packing, packing promptly get.
9. tinidazole gel for eye use according to claim 1 is characterized in that: gel for eye use is meant gel-type eye ointment, gel-type eye drop, gel type eye drop.
10. the purposes of tinidazole gel for eye use is characterized in that: the application of tinidazole gel for eye use in preparation control eye part disease medicine, the tinidazole consumption is 0.1～3.0g in every by weight 100g tinidazole gel for eye use.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727425A (en) * | 2012-07-19 | 2012-10-17 | 厦门大学 | Nitroimidazole oculentum and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727425A (en) * | 2012-07-19 | 2012-10-17 | 厦门大学 | Nitroimidazole oculentum and preparation method thereof |
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Application publication date: 20120718 |