CN1562033A - Gatifloxacin gels foreye and its preparing method - Google Patents
Gatifloxacin gels foreye and its preparing method Download PDFInfo
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- CN1562033A CN1562033A CN200410026893.3A CN200410026893A CN1562033A CN 1562033 A CN1562033 A CN 1562033A CN 200410026893 A CN200410026893 A CN 200410026893A CN 1562033 A CN1562033 A CN 1562033A
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- water
- gatifloxacin
- injection
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- mixed liquor
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- XUBOMFCQGDBHNK-JTQLQIEISA-N (S)-gatifloxacin Chemical compound FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCN[C@@H](C)C1 XUBOMFCQGDBHNK-JTQLQIEISA-N 0.000 title claims description 20
- 229960003923 gatifloxacin Drugs 0.000 title claims description 20
- 239000000499 gel Substances 0.000 title 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 13
- 229960001631 carbomer Drugs 0.000 claims abstract description 12
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 46
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 30
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 24
- 239000003814 drug Substances 0.000 claims description 16
- 239000008215 water for injection Substances 0.000 claims description 16
- 239000012153 distilled water Substances 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 229940079593 drug Drugs 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000000227 grinding Methods 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 238000005498 polishing Methods 0.000 claims description 2
- 238000004659 sterilization and disinfection Methods 0.000 claims description 2
- 230000008961 swelling Effects 0.000 claims description 2
- 229960004418 trolamine Drugs 0.000 abstract description 6
- 239000008213 purified water Substances 0.000 description 9
- 208000024891 symptom Diseases 0.000 description 8
- 239000003889 eye drop Substances 0.000 description 7
- 230000003115 biocidal effect Effects 0.000 description 6
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 6
- RMJMZKDEVNTXHE-UHFFFAOYSA-N 1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid;trihydrate Chemical compound O.O.O.FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCNC(C)C1.FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCNC(C)C1 RMJMZKDEVNTXHE-UHFFFAOYSA-N 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 229960004063 propylene glycol Drugs 0.000 description 5
- 235000013772 propylene glycol Nutrition 0.000 description 5
- 206010020565 Hyperaemia Diseases 0.000 description 4
- 201000007032 bacterial conjunctivitis Diseases 0.000 description 4
- 230000001580 bacterial effect Effects 0.000 description 4
- 206010023332 keratitis Diseases 0.000 description 4
- 230000028327 secretion Effects 0.000 description 4
- 208000001860 Eye Infections Diseases 0.000 description 3
- 229960003405 ciprofloxacin Drugs 0.000 description 3
- 229940012356 eye drops Drugs 0.000 description 3
- 230000035876 healing Effects 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 238000001228 spectrum Methods 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- NLVFBUXFDBBNBW-PBSUHMDJSA-N tobramycin Chemical compound N[C@@H]1C[C@H](O)[C@@H](CN)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O2)O)[C@H](N)C[C@@H]1N NLVFBUXFDBBNBW-PBSUHMDJSA-N 0.000 description 3
- 206010059866 Drug resistance Diseases 0.000 description 2
- 206010064996 Ulcerative keratitis Diseases 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 201000007717 corneal ulcer Diseases 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 229940124307 fluoroquinolone Drugs 0.000 description 2
- CAOOISJXWZMLBN-PPHPATTJSA-N htn0d03vrz Chemical compound Cl.C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 CAOOISJXWZMLBN-PPHPATTJSA-N 0.000 description 2
- 230000003285 pharmacodynamic effect Effects 0.000 description 2
- 229940035275 tobrex Drugs 0.000 description 2
- QCHFTSOMWOSFHM-WPRPVWTQSA-N (+)-Pilocarpine Chemical compound C1OC(=O)[C@@H](CC)[C@H]1CC1=CN=CN1C QCHFTSOMWOSFHM-WPRPVWTQSA-N 0.000 description 1
- JJCZGVLYNIVKKD-UHFFFAOYSA-N 3-hydroxy-2-phenylpropanamide Chemical compound NC(=O)C(CO)C1=CC=CC=C1 JJCZGVLYNIVKKD-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000606161 Chlamydia Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010015943 Eye inflammation Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 description 1
- 241000186359 Mycobacterium Species 0.000 description 1
- 241000204031 Mycoplasma Species 0.000 description 1
- 241000588653 Neisseria Species 0.000 description 1
- 206010034972 Photosensitivity reaction Diseases 0.000 description 1
- QCHFTSOMWOSFHM-UHFFFAOYSA-N SJ000285536 Natural products C1OC(=O)C(CC)C1CC1=CN=CN1C QCHFTSOMWOSFHM-UHFFFAOYSA-N 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229960002537 betamethasone Drugs 0.000 description 1
- UREBDLICKHMUKA-DVTGEIKXSA-N betamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-DVTGEIKXSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- WIIZWVCIJKGZOK-RKDXNWHRSA-N chloramphenicol Chemical compound ClC(Cl)C(=O)N[C@H](CO)[C@H](O)C1=CC=C([N+]([O-])=O)C=C1 WIIZWVCIJKGZOK-RKDXNWHRSA-N 0.000 description 1
- 229940097572 chloromycetin Drugs 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 229960003957 dexamethasone Drugs 0.000 description 1
- -1 dexamethasone compound Chemical class 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- XUBOMFCQGDBHNK-UHFFFAOYSA-N gatifloxacin Chemical compound FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCNC(C)C1 XUBOMFCQGDBHNK-UHFFFAOYSA-N 0.000 description 1
- 238000001879 gelation Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 229960003376 levofloxacin Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 208000007578 phototoxic dermatitis Diseases 0.000 description 1
- 231100000018 phototoxicity Toxicity 0.000 description 1
- 229960001416 pilocarpine Drugs 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 150000007660 quinolones Chemical class 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 229940061354 tequin Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960000707 tobramycin Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
An ocular Jiatishaxing gel contains Jiatishaxing, carbomer and triethanol amine. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of external used medicine for the treatment of ocular infection and preparation method thereof, particularly a kind of spacetabs type eye gel for the treatment of ocular infection and preparation method thereof.
Background technology
So far, the antibiotic medicine of treatment ocular infection disease, kind is few, the aging of product.The antibiotic medicine of present clinical first-selection is ciprofloxacin, tobramycin and dexamethasone compound preparation (trade name: Tobrex).The shortcoming of Tobrex is the price comparison costliness, and by contrast, the price of disposable levofloxacin hydrochloride eye drops is then cheaper.But disposable levofloxacin hydrochloride eye drops is bigger to the eye zest, and the patient is difficult for accepting.Particularly the old antibiotic eye drop of prolonged application causes antibiotic fastbacteria increasing, so this type of antibiotic therapeutical effect weakens; And, also needing multiple dosing on the one during use, the patient is difficult for accepting.
The English name of Gatifloxacin is Gatifloxacin, is abbreviated as GFLX, and the commodity of external listing Tequin by name belongs to novel fluoroquinolone antibacterial agent thing of the 4th generation.From the characteristics of structure and antimicrobial spectrum, have good pharmacokinetics and pharmacodynamic profile, phototoxicity obviously reduces, and is difficult for producing drug resistance, and antimicrobial spectrum is wider.It at first went on the market in the U.S. in December in 1999 on the 27th, was subjected to the welcome of extensive patients deeply.Its characteristics can reduce: 1. has a broad antifungal spectrum.Except that gram negative bacteria being had the strong antibiotic activity, also have than the more powerful resisting gram-positive bacteria of other quinolones and the activity of pathogen such as anaerobe resistant, gonococcus, mycoplasma, chlamydia and mycobacterium.2. antibacterial activity is higher than ciprofloxacin and levofloxacin.3. safety is good.The clinical practice person of having no side effect accounts for 96.5%.Though the report that utilizes GFLX intravenous injection and oral administration treatment eye inflammation is arranged abroad, and effect is better.But this therapeutic modality is very inconvenient to the patient.
Gel for eye is to be adjuvant with natural, semi-synthetic or complete synthesis gel, the pharmaceutical preparation of making.Adjuvant can be selected materials such as polyacrylamide, carbopol 910, carbopol 940 for use.It is big and be easy to and features such as tear mixes that it has viscosity, and prolong drug improves bioavailability in the holdup time on eye surface.The external gel for eye use that medicines such as N-ethyl-N-(.gamma.-picolyl)tropamide, pilocarpine, chloromycetin and betamethasone are arranged of development and Application, but still do not have the report that the GFLX eye-gel preparation is studied at present.
Summary of the invention
The purpose of this invention is to provide a kind of with the Gatifloxacin be main component, have efficient sterilizing, long action time, a spacetabs type gel eye drop that adverse effect is low.
GFLX eye gel of the present invention contains the medicine of following percentage by weight:
Gatifloxacin 0.05%～0.4%
Carbomer 0.5%～1.5%
Triethanolamine 1%～2%
The preferred technical solution of the present invention is the medicine that also comprises following percentage by weight on the basis of such scheme:
Propylene glycol 8%～12%
Glycerol 8%～12%
Distilled water or purified water or water for injection add to 100%
The Gatifloxacin general by name of above-mentioned Gatifloxacin, English name are Gatifloxacin, and molecular formula is C
19H
22FN
3O
41.5H
2O, chemistry 1-cyclopropyl-6 fluoro-7-(3-methyl piperazine-1-yl) by name-8-methoxyl group-1,4-dihydro-4-oxygen-quinoline-3-carboxylic acid 1/2 hydrate; The English name of propylene glycol is PropyleneGlycol; The English name of glycerol is Glycerol; The English name of carbomer is Carbomer; The English name of triethanolamine is Trolamine; The English name of purified water is Purified Water; The English name of water for injection is Water for Injection.
Manufacturing method for above mentioned medicine is for comprising the following steps:
(1) according to dosage gets carbomer and be sprinkled into the glycerol surface, carbomer is mixed fully with glycerol with polishing; Add 150～250ml distilled water or purified water or water for injection and be ground to exquisiteness, add distilled water or purified water or the water for injection of 350～450ml again, make the abundant swelling of carbomer, be statically placed in the container, make mixed liquor (I);
According to dosage get in the distilled water or purified water or water for injection of triethanolamine adding 50～150ml, stirring is fully dissolved it and is made solution (II);
Mixed liquor (I) is added solution (II), continue again to grind, make gel-type vehicle (III);
(2) get an amount of purified water or water for injection or distilled water in addition, according to dosage add Gatifloxacin, stirring is fully dissolved it; According to dosage add propylene glycol again, stir and make its mix homogeneously, make mixed liquor (IV);
(3) under grinding, mixed liquor (IV) is slowly added in the gel-type vehicle (III), again distilled water or purified water or water for injection are added to full dose, continue to be ground to evenly;
(4) aforesaid liquid is carried out just filter and fine straining, carry out fill and sterilization again and promptly get eye gel of the present invention.
The invention has the beneficial effects as follows: because it is the gel rubber sustained-release dosage form, particularly its substrate carbomer has inherent peculiar cross-linked structure, and viscosity that it is good and hydrophilic gel make it have slow releasing function preferably.Therefore this dosage form has the advantage that viscosity is big and be easy to absorb, can prolong drug in the holdup time of mucomembranous surface, thereby fully improve the advantage of the bioavailability of novel fluoroquinolone antibacterial agent thing of the 4th generation of GFLX and pharmaceutics, pharmacodynamics; In clinical practice, can reduce administration time, prolong dosing interval, reduce whole body and absorb the untoward reaction that brings, help improving patient's compliance.Simultaneously, it has overcome old kind medicine to the drug resistance that the patient brings, and has solved the urgent need of clinical eye anti-infectious disease new drug.
Concrete embodiment
Below in conjunction with illustrated embodiments the present invention is described in further detail.
Embodiment one.Gatifloxacin eye gel is to be made by the medicine of following percentage by weight:
Gatifloxacin 0.3%
Propylene glycol 10%
Glycerol 10%
Acritamer 940 1%
Triethanolamine 1.35%
Distilled water or purified water or water for injection add to 100%
It is as follows to utilize medicine of the present invention to carry out the situation of clinical experiment:
Therapeutic Method
Group technology by the order of seeing and treating patients, is divided into 4 groups with 100 routine patients.A, B are the treatment group for two groups, bacterial conjunctivitis 25 examples (A group) wherein, and bacterial keratitis 25 examples (B group) are with the treatment of Gatifloxacin gel eye drop, each 1～2, every day 2 times.C, D are matched group for two groups, bacterial conjunctivitis 25 examples (C group) wherein, and bacterial keratitis 25 examples (D group), with the treatment of 0.3% ciprofloxacin eye drops, each 1～2, per 2 hours are once.
The treatment standard
Bacterial conjunctivitis is cured: subjective symptoms, hyperemia and secretions disappear; Produce effects: subjective symptoms alleviates, and hyperemia alleviates, and secretions reduces; Invalid: symptom no change or subjective symptoms increase the weight of.
Bacterial keratitis is cured: subjective symptoms, hyperemia and secretions disappear, the corneal ulcer healing; Produce effects: subjective symptoms alleviates, hyperemia alleviates, secretions reduces, the little or minimizing of corneal ulcer reduction of area; Invalid: symptom no change or subjective symptoms increase the weight of.
Therapeutic outcome
The clinical effectiveness of Gatifloxacin gel eye drop
The bacterial conjunctivitis bacterial keratitis
Not healing meter x is cured in grouping
2Not healing meter x is cured in the grouping of value P value
2Value P value
(％) (％) (％) (％)
Treatment group A 24 1 25 B 23 2 25
(96) (4) 4.15 ＜0.05 (92) (8) 4.5 ＜0.05
Matched group C 19 6 25 C 17 8 25
(76) (24) (68) (32)
Claims (4)
1. Gatifloxacin eye gel is characterized in that containing the medicine of following percentage by weight:
Gatifloxacin 0.05%-0.4%
Carbomer 0.5%-1.5%
Triethanolamine 1%-2%
2. Gatifloxacin eye gel according to claim 1 is characterized in that also containing the medicine of following percentage by weight:
Propylene glycol 8%-12%
Glycerol 8%-12%
Distilled water or pure water or water for injection add to 100%
3. Gatifloxacin eye gel according to claim 1 and 2 is characterized in that being made by the medicine of following percentage by weight:
Gatifloxacin 0.3%
Propylene glycol 10%
Glycerol 10%
Acritamer 940 1%
Triethanolamine 1.35%
Distilled water or pure water or water for injection add to 100%
4. according to the preparation method of claim 1 or 2 or 3 described medicines, it is characterized in that comprising the following steps:
(1) according to dosage gets carbomer and be sprinkled into the glycerol surface, carbomer is mixed fully with glycerol with polishing; Add 150-250ml distilled water or pure water or water for injection and be ground to exquisiteness, add distilled water or pure water or the water for injection of 350-450ml again, make the abundant swelling of carbomer, be statically placed in the container, make mixed liquor (I);
According to dosage get in the distilled water or pure water or water for injection of triethanolamine adding 50-150ml, stirring is fully dissolved it and is made mixed liquor (II);
Mixed liquor (I) is added mixed liquor (II), continue again to grind, make gel-type vehicle (III);
(2) get an amount of distilled water or pure water or water for injection in addition, according to dosage add Gatifloxacin, stirring is fully dissolved it; According to dosage add propylene glycol again, stir and make its mix homogeneously, make mixed liquor (IV);
(3) under grinding, mixed liquor (IV) is slowly added in the gel-type vehicle (III), again distilled water or pure water or water for injection are added to full dose, continue to be ground to evenly;
(4) aforesaid liquid is carried out just filter and fine straining, carry out fill and sterilization again and promptly get eye of the present invention gelling.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200410026893.3A CN1215844C (en) | 2004-04-18 | 2004-04-18 | Gatifloxacin gels foreye and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200410026893.3A CN1215844C (en) | 2004-04-18 | 2004-04-18 | Gatifloxacin gels foreye and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1562033A true CN1562033A (en) | 2005-01-12 |
| CN1215844C CN1215844C (en) | 2005-08-24 |
Family
ID=34480785
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200410026893.3A Expired - Fee Related CN1215844C (en) | 2004-04-18 | 2004-04-18 | Gatifloxacin gels foreye and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1215844C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1307995C (en) * | 2005-10-12 | 2007-04-04 | 周卓和 | Gatifloxacin eye drop and its preparing method |
| WO2011063606A1 (en) * | 2009-11-27 | 2011-06-03 | 沈阳兴齐制药有限公司 | Ophthalmic gel of gatifloxacin and preparation method thereof |
| CN103142463A (en) * | 2013-03-05 | 2013-06-12 | 宁夏康亚药业有限公司 | Eye medicament composition as well as preparation method and application thereof |
-
2004
- 2004-04-18 CN CN200410026893.3A patent/CN1215844C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1307995C (en) * | 2005-10-12 | 2007-04-04 | 周卓和 | Gatifloxacin eye drop and its preparing method |
| WO2011063606A1 (en) * | 2009-11-27 | 2011-06-03 | 沈阳兴齐制药有限公司 | Ophthalmic gel of gatifloxacin and preparation method thereof |
| US8901131B2 (en) | 2009-11-27 | 2014-12-02 | Shenyang Xingqi Pharmaceutical Co., Ltd. | Gatifloxacin-containing ophthalmic gel and preparation method thereof |
| CN103142463A (en) * | 2013-03-05 | 2013-06-12 | 宁夏康亚药业有限公司 | Eye medicament composition as well as preparation method and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1215844C (en) | 2005-08-24 |
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