CN101461777A - Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof - Google Patents
Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof Download PDFInfo
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- CN101461777A CN101461777A CNA2009100736052A CN200910073605A CN101461777A CN 101461777 A CN101461777 A CN 101461777A CN A2009100736052 A CNA2009100736052 A CN A2009100736052A CN 200910073605 A CN200910073605 A CN 200910073605A CN 101461777 A CN101461777 A CN 101461777A
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Abstract
The invention discloses disposable levofloxacin hydrochloride eye drops and a preparation method thereof. The disposable levofloxacin hydrochloride eye drops comprise levofloxacin hydrochloride, a pH regulator, an isotonic agent, a stabilizing agent, a thickening agent, and the like; and the preparation method adopts a bacteria-free bottling process or an autoclaving process. In addition, the eye drops are independently packaged in single dose for disposable use, thereby the sterility performance of products is guaranteed and the products are more safe, reliable, simple, convenient, and sanitary.
Description
Technical field
The invention belongs to pharmaceutical field, levofloxacin hydrochloride eye drop of particularly disposable not bacteriostatic agent and preparation method thereof.
Background technology
The levofloxacin hydrochloride eye drop is used for the treatment of diseases such as bacterial conjunctivitis that sensitive bacterial causes, bacterial keratitis.The levofloxacin hydrochloride eye drop that has gone on the market is multiple-unit container, is repeatedly used.Preparation is in case behind the Kaifeng, easily use and the preservation process in by tear and airborne microbial contamination, and then produce safety hidden danger.For prevent ophthalmic preparation behind Kaifeng in the repeated use process by the microorganism secondary pollution, all added antibacterial (preservative) in the ophthalmic preparation, all used antibacterial in the nearly all eye drop prescription in " Chinese Hospitals preparation standard ".Antibacterial claims antiseptic or preservative agent again, is meant to suppress pathogenic microorganism growth and the chemical drugs of breeding, and its primary application in pharmacy practice is exactly the microbial contamination that prevents medicine.
Though antibacterial is preventing aspect the microbial contamination certain positive effect is arranged, the untoward reaction of antibacterial also progressively is familiar with by people.It is reported antibacterial existence to the superficial cell of eye can produce zest (list of references: Liu Aiming, Li Wei, Wang Benmin, " the eye table infringement of antibacterial in the ophthalmic preparation " Chinese Hospitals pharmaceutical journal, 2002,22 (6), 371-373).The antibacterial composition can directly influence the composition of tear in the eye drop, change the microenvironment of eyeball surface, make close-connected epithelial cell structural damage originally, exfoliation of corneal epithelium, damaged, epithelial erosion appear in severe patient, corneal ulcer can take place, even corneal solution, perforation, blind.The problem that causes by antibacterial abuse more and more receive publicity (list of references: Ning Lili, " should pay close attention to the reasonable use and the quality control of antibacterial in the ophthalmic preparation R﹠D process " Chinese Hospitals pharmaceutical journal, 2007,42 (23), 1836-1838).Especially for the frequent eye drop that uses of needs, its potential danger is bigger.
Do not add antibacterial (2002 and the towering import successively of Japan in 2004 are not added antibacterial to Chinese levofloxacin hydrochloride eye drop (0.3%) and left levofloxacin hydrochloride eye drop (0.5%) in the prescription) from the multiple-unit container levofloxacin hydrochloride eye drop of Japanese import on the market.Although levofloxacin hydrochloride itself has certain antibiotic effect, but whether its bacteriostasis efficacy can not add the criterion (list of references: Ning Lili of antibacterial as ophthalmic preparation, Zhao Deheng, State Food and Drug Administration's medicine is commented the center, Shen " the multiple dose ophthalmic preparation not to be added the thinking of antibacterial ", electronic journal 2008-9-12).Therefore, still there is much controversy, do not gain unanimous acceptance as yet for the safety of bacteriostatic agent multiple dose ophthalmic preparation not.
Summary of the invention
The technical problem to be solved in the present invention provides levofloxacin hydrochloride eye drop of a kind of disposable not bacteriostatic agent and preparation method thereof, and it can avoid the untoward reaction that eyes caused because of the ophthalmic preparation that uses bacteriostatic agent; And can prevent to use the not issuable potential risk of ophthalmic preparation of bacteriostatic agent multiple dose.
For solving the problems of the prior art, the present invention is achieved by the following technical solutions:
The levofloxacin hydrochloride eye drop of the disposable not bacteriostatic agent of the present invention, it comprises following component:
Levofloxacin hydrochloride 2.97~3.63g
PH regulator agent 0.1~50g
Isotonic agent 0.1~50g
Add the injection water and be settled to 1000mL
Described pH regulator agent is that in sodium dihydrogen phosphate, sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, boric acid, Borax, acetic acid, sodium acetate, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium carbonate, potassium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, the phosphoric acid one or more are composite.
The effect of pH regulator agent is to equate with the acid-base value of tear or approaching for the acid-base value that makes eye drop, reducing the zest of eye drop, and makes medicine stable, improves drug effect.The levofloxacin hydrochloride eye drop pH scope of described not bacteriostatic agent is: 5.0~7.0.
Described isotonic agent is that in sodium chloride, potassium chloride, boric acid, Borax, sodium sulfate, potassium sulfate, Chile saltpeter, potassium nitrate, sodium acetate, mannitol, glycerol, propylene glycol, the glucose one or more are composite.
The effect of isotonic agent is to equate with the osmotic pressure of tear or approaching for the osmotic pressure that makes eye drop, to reduce the zest of eye drop, improves drug effect.
The levofloxacin hydrochloride eye drop of described disposable not bacteriostatic agent, it also comprises one or more assembly in stabilizing agent, the thickening agent:
Described stabilizing agent is: 0.01~5g
Described thickening agent is: 0.01~10g
Described stabilizing agent is that in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium nitrite, sodium thiosulfate, ascorbic acid (vitamin C), thiourea, ascorbyl stearate, dibutyl hydroxy toluene, cysteine, tocopherol acetas, dichloro isocyanide, disodiumedetate (EDTA-2Na, disodium edetate), calcio-disodium edetate, dimercaptopropanol, BAL, glycerol, mannitol, the butylated hydroxyanisol one or more are composite.
Function of stabilizer is in order to increase the stability of eye drop, to improve drug effect.
Described thickening agent is that in hyaluronate sodium, chondroitin sulfate, methylcellulose, hydroxy methocel, hydroxypropyl methylcellulose, cellulose, polyvidone, polyvinylpyrrolidone, polyvinyl alcohol, chitosan, beta cyclodextrin, carbomer, glucosamine polymer, glycerol, propylene glycol, Polyethylene Glycol, the polyvinyl alcohol one or more are composite.
But the time that the thickening agent prolong drug stops within the eye can reduce simultaneously the zest to eye, improves drug effect.
The preparation method of the levofloxacin hydrochloride eye drop of described disposable not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing levofloxacin hydrochloride 2.97~3.63g, pH regulator agent 0.1~50g, isotonic agent 0.1~50g, stabilizing agent 0.01~5g, 1/5~1/4 dissolving that adds the water for injection total amount, mix, the adjust pH scope is: 5.0~7.0, be settled to 1000mL with water for injection, get medicinal liquid.
B. under hundred grades of environment, with step a gained medicinal liquid with 0.22~0.45 μ m filtering with microporous membrane 1 to 5 time.
C. medicinal liquid detect qualified after, under hundred grades of environment, liquid drug is sealed to the unit dose package container, gets product.Said method is called sterile working's filling process.
In above-mentioned steps b process, also can at first use 0.45 μ m filtering with microporous membrane, make clarity qualified after, re-use 0.22 μ m filtering with microporous membrane, also can suitably increase the filtration number of times according to practical condition.The levofloxacin hydrochloride eye drop of not bacteriostatic agent of the present invention should meet that " Chinese pharmacopoeia is to the requirement under the eye drop item.
Preferably, the preparation method of the levofloxacin hydrochloride eye drop of described disposable not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing levofloxacin hydrochloride 2.97~3.63g, pH regulator agent 0.1~50g, isotonic agent 0.1~50g, stabilizing agent 0.01~5g, 1/5~1/4 dissolving that adds the water for injection total amount, mix, the adjust pH scope is: 5.0~7.0, be settled to 1000mL with water for injection, get medicinal liquid.
B. under hundred grades of environment, with step a gained medicinal liquid with 0.22~0.45 μ m filtering with microporous membrane 1 to 5 time.
C. with step b gained medicinal liquid pressure sterilizing.
D. testing sequence c gained medicinal liquid, qualified after, under hundred grades of environment, liquid drug is sealed to the unit dose package container, gets product.Said method claims pressure sterilizing technology.
In step c, should be according to " the desired condition of Chinese pharmacopoeia sterilizing methods guarantees that aseptic level must not be higher than 10
-6, that is: aseptic level must not be higher than 1,000,000/, F
0Value is greater than 8.
Preferably, (or claim: low dose of independent packaging), the volume scope of the container of described single dose independent packaging is 0.1~5.0 milliliter/to the independent packaging of the levofloxacin hydrochloride eye drop of described disposable not bacteriostatic agent employing single dose.
The eye drop finished product adopts the plastics independent packaging of disposable single dose usually.
Preferably, the levofloxacin hydrochloride eye drop of described disposable not bacteriostatic agent, the medicine liquid volume scope that adopts the single dose independent packaging is 0.01~5.0 milliliter/.
The eye drop finished product should meet that " Chinese pharmacopoeia is to the requirement under the eye drop item, and should meet country's other correlated quality requirement to the levofloxacin hydrochloride eye drop.
After each single dose individual packets is contained in and uses at every turn, no longer reuse.Can be made into one or more groups single dose eye drop finished product during production.
The beneficial effect that the present invention is compared with prior art had is:
One, eye drop of the present invention bacteriostatic agent has not been avoided because the potential danger that antibacterial causes and to the toxic and side effects of eyes uses product of the present invention safer, reliable.
Two, the present invention adopts sterile working's filling process production or sterilization process production, has guaranteed the aseptic requirement of product.
Three, the present invention adopts the single dose independent packaging, discards after the disposable use, and medicinal liquid can not be secondary polluted, and the integrity of other single dose independent packaging is unaffected.
Four, product of the present invention bacteriostatic agent has not been saved the cost that multiple-unit container must add adjuvants such as antibacterial.
The specific embodiment
Below the present invention is further illustrated by specific embodiment.
Embodiment one
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g levofloxacin hydrochloride, 7.24g sodium dihydrogen phosphate, 0.94g sodium hydrogen phosphate, 12.0g glycerol, adds the dissolving of 200mL water for injection, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. with above-mentioned medicinal liquid with 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, reuse 0.22 μ m filtering with microporous membrane 2 times.
C. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 0.5mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment two
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g levofloxacin hydrochloride, 12.0g boric acid, 0.6g Borax, 2.1g sodium chloride, adds the dissolving of 200mL water for injection, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. with the medicinal liquid of above-mentioned preparation, with 0.45 μ m filtering with microporous membrane 1 time, reuse 0.22 μ m filtering with microporous membrane 1 time.
C. filtered liquid medicine adopts autoclaving, sterilizes 8 minutes cooling down in 121 ℃.
D. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 0.4mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment three
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g levofloxacin hydrochloride, 6.4g sodium dihydrogen phosphate, 1.9g sodium hydrogen phosphate, 4.6g sodium chloride, 1.0g hyaluronic acid sodium, adds the dissolving of 200mL water for injection, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. with above-mentioned medicinal liquid with 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, reuse 0.22 μ m filtering with microporous membrane 2 times.
C. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 0.4mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment four
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g levofloxacin hydrochloride, 1.0g citric acid, 22.0g glycerol, adds the dissolving of 200mL water for injection, regulates pH to 5.0~7.0 with 5% sodium hydroxide solution, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. with the medicinal liquid of above-mentioned preparation, with 0.45 μ m filtering with microporous membrane 1 time, reuse 0.22 μ m filtering with microporous membrane 1 time.
C. filtered liquid medicine adopts autoclaving, sterilizes 8 minutes cooling down in 121 ℃.
D. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 0.8mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment five
Prescription:
Its preparation method:
A. precision takes by weighing the 1.0g hyaluronic acid sodium, adds 300mL water for injection and makes it dissolving, and constant temperature stirs for 50~70 ℃ and made it reach sufficient swelling in 12 hours, cooling, and it is standby to get solution 1; Precision takes by weighing 3.3g levofloxacin hydrochloride, 12.0g boric acid, 0.6g Borax, 2.1g sodium chloride, and with 200mL water for injection stirring and dissolving, it is standby to get solution 2; Solution 1 and solution 2 are mixed, after stirring, be settled to 1000mL, get medicinal liquid with water for injection.
B. with above-mentioned medicinal liquid with 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, reuse 0.22 μ m filtering with microporous membrane 2 times.
C. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 1.0mL seals to 2mL unit dose package plastic containers, gets product.
Embodiment six
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g levofloxacin hydrochloride, 6.4g sodium dihydrogen phosphate, 1.9g sodium hydrogen phosphate, 28.0g glucose, 1.0g sodium sulfite, 0.1g ethylenediamine tetrem disodium, add the dissolving of 200mL water for injection, after stirring, be settled to 1000mL, get medicinal liquid with water for injection.
B. with the medicinal liquid of above-mentioned preparation, with 0.45 μ m filtering with microporous membrane 1 time, reuse 0.22 μ m filtering with microporous membrane 1 time.
C. filtered liquid medicine adopts autoclaving, sterilizes 8 minutes cooling down in 121 ℃.
D. medicinal liquid after the assay was approved, under hundred grades of environment, the above-mentioned medicinal liquid of fill 0.4mL seals to 1mL unit dose package plastic containers, gets product.
Prescription is example with 1000mL all in the embodiment of the invention, can be with reference to the corresponding increase amount of preparation of prescription ratio in the actual industrial production.
Claims (6)
1, the levofloxacin hydrochloride eye drop of disposable not bacteriostatic agent is characterized in that it comprises following component:
Levofloxacin hydrochloride 2.97~3.63g
PH regulator agent 0.1~50g
Isotonic agent 0.1~50g
Add the injection water and be settled to 1000mL
Described pH regulator agent is that in sodium dihydrogen phosphate, sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, boric acid, Borax, acetic acid, sodium acetate, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium carbonate, potassium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, the phosphoric acid one or more are composite;
Described isotonic agent is that in sodium chloride, potassium chloride, boric acid, Borax, sodium sulfate, potassium sulfate, Chile saltpeter, potassium nitrate, sodium acetate, mannitol, glycerol, propylene glycol, the glucose one or more are composite.
2, the levofloxacin hydrochloride eye drop of disposable not bacteriostatic agent as claimed in claim 1 is characterized in that it also comprises one or more assembly in stabilizing agent, the thickening agent:
Described stabilizing agent is: 0.01~5g
Described thickening agent is: 0.01~10g
Described stabilizing agent is that in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium nitrite, sodium thiosulfate, ascorbic acid (vitamin C), thiourea, ascorbyl stearate, dibutyl hydroxy toluene, cysteine, tocopherol acetas, dichloro isocyanide, disodiumedetate (EDTA-2Na, disodium edetate), calcio-disodium edetate, dimercaptopropanol, BAL, glycerol, mannitol, the butylated hydroxyanisol one or more are composite;
Described thickening agent is that in hyaluronate sodium, chondroitin sulfate, methylcellulose, hydroxy methocel, hydroxypropyl methylcellulose, cellulose, polyvidone, polyvinylpyrrolidone, polyvinyl alcohol, chitosan, beta cyclodextrin, carbomer, glucosamine polymer, glycerol, propylene glycol, Polyethylene Glycol, the polyvinyl alcohol one or more are composite.
3, as the preparation method of the levofloxacin hydrochloride eye drop of claim 1 or the described disposable not bacteriostatic agent of claim 2, it is characterized in that it may further comprise the steps:
A. precision takes by weighing levofloxacin hydrochloride 2.97~3.63g, pH regulator agent 0.1~50g, isotonic agent 0.1~50g, stabilizing agent 0.01~5g, 1/5~1/4 dissolving that adds the water for injection total amount, mix, the adjust pH scope is: 5.0~7.0, be settled to 1000mL with water for injection, get medicinal liquid;
B. under hundred grades of environment, with step a gained medicinal liquid with 0.22~0.45 μ m filtering with microporous membrane 1 to 5 time;
C. testing sequence b gained medicinal liquid, qualified after, under hundred grades of environment, liquid drug is sealed to the unit dose package container, gets product.
4, as the preparation method of the levofloxacin hydrochloride eye drop of claim 1 or the described disposable not bacteriostatic agent of claim 2, it is characterized in that it may further comprise the steps:
A. precision takes by weighing levofloxacin hydrochloride 2.97~3.63g, pH regulator agent 0.1~50g, isotonic agent 0.1~50g, stabilizing agent 0.01~5g, 1/5~1/4 dissolving that adds the water for injection total amount, mix, the adjust pH scope is: 5.0~7.0, be settled to 1000mL with water for injection, get medicinal liquid;
B. under hundred grades of environment, with step a gained medicinal liquid with 0.22~0.45 μ m filtering with microporous membrane 1 to 5 time;
C. with step b gained medicinal liquid pressure sterilizing;
D. testing sequence c gained medicinal liquid, qualified after, under hundred grades of environment, liquid drug is sealed to the unit dose package container, gets product.
5, the levofloxacin hydrochloride eye drop of disposable not bacteriostatic agent as claimed in claim 1 or 2, it is characterized in that: described levofloxacin hydrochloride eye drop adopts the single dose independent packaging, and the volume scope of the container of described single dose independent packaging is 0.1~5.0 milliliter/.
6, the levofloxacin hydrochloride eye drop of disposable not bacteriostatic agent as claimed in claim 5 is characterized in that: the medicine liquid volume scope of described single dose independent packaging is 0.01~5.0 milliliter/.
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Cited By (11)
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CN101987084B (en) * | 2009-07-31 | 2012-05-09 | 天津市医药科学研究所 | Chitosan-collagen sustained-release eye drop and preparation method |
CN102949334A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Levofloxacin hydrochloride gel-type eye-drops |
CN103432069A (en) * | 2013-09-12 | 2013-12-11 | 安徽环球药业股份有限公司 | Ofloxacin eye drop without bacteriostatic agent and preparation method of ofloxacin eye drop |
CN104414968A (en) * | 2013-09-09 | 2015-03-18 | 南京长澳医药科技有限公司 | Levofloxacin single-dose eye drops and preparation method thereof |
CN104739757A (en) * | 2013-12-31 | 2015-07-01 | 黄晓平 | Haze nasal drop |
CN106138502A (en) * | 2016-08-22 | 2016-11-23 | 周艳 | A kind of Chinese and Western compound recipe collyrium treating bacterial keratitis and preparation method |
CN106236706A (en) * | 2016-08-31 | 2016-12-21 | 广东宏盈科技有限公司 | A kind of levofloxacin hydrochloride slow release eye drop |
CN110101657A (en) * | 2019-06-14 | 2019-08-09 | 深圳市瑞霖医药有限公司 | A kind of lavo-ofloxacin single dose eye drops and preparation method thereof |
CN110141550A (en) * | 2019-07-09 | 2019-08-20 | 武汉兴华智慧医药科技有限公司 | A kind of lavo-ofloxacin oral administration solution and preparation method thereof |
CN110876714A (en) * | 2019-11-22 | 2020-03-13 | 南京知和医药科技有限公司 | Levofloxacin sustained-release eye drops and preparation process thereof |
CN112190558A (en) * | 2020-10-20 | 2021-01-08 | 迪沙药业集团有限公司 | Levofloxacin composition |
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2009
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CN101987084B (en) * | 2009-07-31 | 2012-05-09 | 天津市医药科学研究所 | Chitosan-collagen sustained-release eye drop and preparation method |
CN102949334A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Levofloxacin hydrochloride gel-type eye-drops |
CN104414968A (en) * | 2013-09-09 | 2015-03-18 | 南京长澳医药科技有限公司 | Levofloxacin single-dose eye drops and preparation method thereof |
CN104414968B (en) * | 2013-09-09 | 2018-10-02 | 珠海亿胜生物制药有限公司 | A kind of lavo-ofloxacin single dose eye drops and preparation method thereof |
CN103432069A (en) * | 2013-09-12 | 2013-12-11 | 安徽环球药业股份有限公司 | Ofloxacin eye drop without bacteriostatic agent and preparation method of ofloxacin eye drop |
CN104739757A (en) * | 2013-12-31 | 2015-07-01 | 黄晓平 | Haze nasal drop |
CN106138502A (en) * | 2016-08-22 | 2016-11-23 | 周艳 | A kind of Chinese and Western compound recipe collyrium treating bacterial keratitis and preparation method |
CN106236706A (en) * | 2016-08-31 | 2016-12-21 | 广东宏盈科技有限公司 | A kind of levofloxacin hydrochloride slow release eye drop |
CN110101657A (en) * | 2019-06-14 | 2019-08-09 | 深圳市瑞霖医药有限公司 | A kind of lavo-ofloxacin single dose eye drops and preparation method thereof |
CN110141550A (en) * | 2019-07-09 | 2019-08-20 | 武汉兴华智慧医药科技有限公司 | A kind of lavo-ofloxacin oral administration solution and preparation method thereof |
CN110876714A (en) * | 2019-11-22 | 2020-03-13 | 南京知和医药科技有限公司 | Levofloxacin sustained-release eye drops and preparation process thereof |
CN112190558A (en) * | 2020-10-20 | 2021-01-08 | 迪沙药业集团有限公司 | Levofloxacin composition |
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