CN101461778A - 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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- CN101461778A CN101461778A CNA2009100736067A CN200910073606A CN101461778A CN 101461778 A CN101461778 A CN 101461778A CN A2009100736067 A CNA2009100736067 A CN A2009100736067A CN 200910073606 A CN200910073606 A CN 200910073606A CN 101461778 A CN101461778 A CN 101461778A
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Abstract
The invention discloses bacteriostat-free ciprofloxacin hydrochloride eye drops and a preparation method thereof. The bacteriostat-free ciprofloxacin hydrochloride eye drops comprise ciprofloxacin 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 disposable single dose, 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, particularly disposable levofloxacin hydrochloride eye drops of bacteriostatic agent and preparation method thereof not.
Background technology
Disposable levofloxacin hydrochloride eye drops is used for the treatment of responsive microbial outer eye to be infected.The disposable levofloxacin hydrochloride eye drops that has gone on the market all contains antibacterial, 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.
Summary of the invention
The technical problem to be solved in the present invention provides disposable levofloxacin hydrochloride eye drops of a kind of not bacteriostatic agent and preparation method thereof, it can avoid the secondary pollution of microorganism in using the eye drop process, also can avoid toxic and side effects and the potential risk that antibacterial causes eyes in the prior art simultaneously.
For solving the problems of the prior art, the present invention is achieved by the following technical solutions:
The present invention is the disposable levofloxacin hydrochloride eye drops of bacteriostatic agent not, and it comprises following component:
Ciprofloxacin 3.0～3.66g
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 disposable levofloxacin hydrochloride eye drops pH scope of described not bacteriostatic agent is: 4.0～5.0.
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 disposable levofloxacin hydrochloride eye drops of described 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 disposable levofloxacin hydrochloride eye drops of described not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing ciprofloxacin 3.0～3.66g, pH regulator agent 0.1～50g, isotonic agent 0.1～50g, stabilizing agent 0.01～5g, add 1/5～1/4 dissolving of water for injection total amount, transfer the pH scope to be: 4.0～5.0, mix, be settled to 1000mL with water for injection, get medicinal liquid.
B. under hundred grades of environment, with step a gained medicinal liquid through 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 disposable levofloxacin hydrochloride eye drops 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 disposable levofloxacin hydrochloride eye drops of described not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing ciprofloxacin 3.0～3.66g, pH regulator agent 0.1～50g, isotonic agent 0.1～50g, stabilizing agent 0.01～5g, add 1/5～1/4 dissolving of water for injection total amount, transfer the pH scope to be: 4.0～5.0, mix, be settled to 1000mL with water for injection, get medicinal liquid.
B. under hundred grades of environment, with step a gained medicinal liquid through 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 disposable levofloxacin hydrochloride eye drops of described not bacteriostatic agent employing single dose.
The eye drop finished product adopts the plastics independent packaging of disposable single dose usually.
Preferably, the disposable levofloxacin hydrochloride eye drops of described 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 disposable levofloxacin hydrochloride eye drops.
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 ciprofloxacin, 11.8g boric acid, 5.0g glycerol, adds the dissolving of 200mL water for injection, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. above-mentioned medicinal liquid is through 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, again through 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 two
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g ciprofloxacin, 11.2g boric acid, 1.7g 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 the medicinal liquid of above-mentioned preparation, through 0.45 μ m filtering with microporous membrane 1 time, again through 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 0.5mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment three
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g ciprofloxacin, 0.33g sodium acetate, 0.42g acetic acid, 22.0g glycerol, adds the dissolving of 200mL water for injection, after stirring, is settled to 1000mL with water for injection, gets medicinal liquid.
B. with the medicinal liquid of above-mentioned preparation, through 0.45 μ m filtering with microporous membrane 1 time, again through 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 four
Prescription:
Its preparation method:
A. precision takes by weighing the 0.6g 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 ciprofloxacin, 0.33g sodium acetate, 0.42g acetic acid, 42.0g mannitol, add 200mL water for injection dissolving after, it is mixed, solution 2 is standby; Solution 1 and solution 2 are mixed, after stirring, be settled to 1000mL, get medicinal liquid with water for injection.
B. above-mentioned medicinal liquid is through 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, again through 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 five
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g ciprofloxacin, 0.33g sodium acetate, 0.42g acetic acid, 48.0g glucose, 0.5g sodium sulfite, 0.1g ethylenediamine tetrem disodium, add the dissolving of 200mL water for injection, it is mixed, be settled to 1000mL, get medicinal liquid with water for injection.
B. with the medicinal liquid of above-mentioned preparation, through 0.45 μ m filtering with microporous membrane 1 time, again through 0.22 μ m filtering with microporous membrane 1 time.
C. filtered liquid medicine adopts autoclaving, sterilizes 32 minutes cooling down in 115 ℃.
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 six
Prescription:
Its preparation method:
A. precision takes by weighing 3.3g ciprofloxacin, 0.33g sodium acetate, 0.42g acetic acid, 42.0g mannitol, 0.6g hyaluronic acid sodium, 0.5g sodium sulfite, 0.1g ethylenediamine tetrem disodium, add the dissolving of 200mL water for injection, fully mix, be settled to 1000mL, get medicinal liquid with water for injection.
B. above-mentioned medicinal liquid is through 0.45 μ m filtering with microporous membrane 1 time, under hundred grades of environment, again through 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 0.6mL 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 disposable levofloxacin hydrochloride eye drops of bacteriostatic agent not is characterized in that it comprises following component:
Ciprofloxacin 3.0～3.66g
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 disposable levofloxacin hydrochloride eye drops of 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 disposable levofloxacin hydrochloride eye drops of claim 1 or the described not bacteriostatic agent of claim 2, it is characterized in that it may further comprise the steps:
A. precision takes by weighing ciprofloxacin 3.0～3.66g, pH regulator agent 0.1～50g, isotonic agent 0.1～50g, stabilizing agent 0.01～5g, add 1/5～1/4 dissolving of water for injection total amount, transfer the pH scope to be: 4.0～5.0, mix, be settled to 1000mL with water for injection, get medicinal liquid;
B. under hundred grades of environment, with step a gained medicinal liquid through 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 disposable levofloxacin hydrochloride eye drops of claim 1 or the described not bacteriostatic agent of claim 2, it is characterized in that it may further comprise the steps:
A. precision takes by weighing ciprofloxacin 3.0～3.66g, pH regulator agent 0.1～50g, isotonic agent 0.1～50g, stabilizing agent 0.01～5g, add 1/5～1/4 dissolving of water for injection total amount, transfer the pH scope to be: 4.0～5.0, mix, be settled to 1000mL with water for injection, get medicinal liquid;
B. under hundred grades of environment, with step a gained medicinal liquid through 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 disposable levofloxacin hydrochloride eye drops of not bacteriostatic agent as claimed in claim 1 or 2, it is characterized in that: the disposable levofloxacin hydrochloride eye drops of described not bacteriostatic agent 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 disposable levofloxacin hydrochloride eye drops of 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/.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100736067A CN101461778A (en) | 2009-01-06 | 2009-01-06 | Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100736067A CN101461778A (en) | 2009-01-06 | 2009-01-06 | Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof |
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|---|---|
| CN101461778A true CN101461778A (en) | 2009-06-24 |
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|---|---|---|---|
| CNA2009100736067A Pending CN101461778A (en) | 2009-01-06 | 2009-01-06 | Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836950A (en) * | 2010-03-12 | 2010-09-22 | 陕西合成药业有限公司 | Moxifloxacin hydrochloride glucose injection and preparation method and use thereof |
| CN102512362A (en) * | 2011-12-21 | 2012-06-27 | 无锡济民可信山禾药业股份有限公司 | Formula and preparation method of compound ciprofloxacin eye drops |
| US11166974B2 (en) | 2012-03-26 | 2021-11-09 | Santen Pharmaceutical Co., Ltd. | Ophthalmic solution comprising Diquafosol |
| WO2022036794A1 (en) * | 2020-08-18 | 2022-02-24 | 山东绅联生物科技有限公司 | Method for preparing single-dose cyclopentolate hydrochloride eye drop |
-
2009
- 2009-01-06 CN CNA2009100736067A patent/CN101461778A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836950A (en) * | 2010-03-12 | 2010-09-22 | 陕西合成药业有限公司 | Moxifloxacin hydrochloride glucose injection and preparation method and use thereof |
| CN102512362A (en) * | 2011-12-21 | 2012-06-27 | 无锡济民可信山禾药业股份有限公司 | Formula and preparation method of compound ciprofloxacin eye drops |
| CN102512362B (en) * | 2011-12-21 | 2013-07-10 | 无锡济民可信山禾药业股份有限公司 | Formula and preparation method of compound ciprofloxacin eye drops |
| US11166974B2 (en) | 2012-03-26 | 2021-11-09 | Santen Pharmaceutical Co., Ltd. | Ophthalmic solution comprising Diquafosol |
| TWI757799B (en) * | 2012-03-26 | 2022-03-11 | 日商參天製藥股份有限公司 | Manufacturing method of aqueous ophthalmic solution |
| WO2022036794A1 (en) * | 2020-08-18 | 2022-02-24 | 山东绅联生物科技有限公司 | Method for preparing single-dose cyclopentolate hydrochloride eye drop |
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Open date: 20090624 |