CN101455637A - Bendazac lysine eye drops without bacteria inhibitor and preparation method thereof - Google Patents
Bendazac lysine eye drops without bacteria inhibitor and preparation method thereof Download PDFInfo
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- CN101455637A CN101455637A CNA2009100736160A CN200910073616A CN101455637A CN 101455637 A CN101455637 A CN 101455637A CN A2009100736160 A CNA2009100736160 A CN A2009100736160A CN 200910073616 A CN200910073616 A CN 200910073616A CN 101455637 A CN101455637 A CN 101455637A
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Abstract
The present invention discloses bendazac lysine eye drops which do not contain bacteriostat and a preparing method thereof, wherein the bendazac lysine eye drops comprise bendazac lysine, pH modifying agent, isoosmotic agent, stabilizing agent, thickening agent, etc. The preparing method adopts an aseptic manipulation filling technique or a hot pressing sterilizing technique. Furthermore the eye drops of the invention adopt a disposable single-dose independent packaging. The sterilized performance of product is guaranteed. The product is safer, more reliable, easier and more sanitary.
Description
Technical field
The invention belongs to pharmaceutical field, particularly Benzydalysine eye drop of bacteriostatic agent and preparation method thereof not.
Background technology
Benzydalysine eye drop is used for cataractous prevention and treatment.The Benzydalysine eye drop 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 (see document: 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 (see document: 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 Benzydalysine eye drop 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 Benzydalysine eye drop of bacteriostatic agent not, and it comprises following component:
Bendazac lysine 4.5～5.5g
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 Benzydalysine eye drop pH scope of described not bacteriostatic agent is: 6.8～7.8.
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 Benzydalysine eye drop 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 Benzydalysine eye drop of described not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing bendazac lysine 4.5～5.5g, 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: 6.8～7.8, 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 Benzydalysine 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 Benzydalysine eye drop of described not bacteriostatic agent, it may further comprise the steps:
A. precision takes by weighing bendazac lysine 4.5～5.5g, 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: 6.8～7.8, 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 Benzydalysine eye drop 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 Benzydalysine eye drop 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.
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 5.0g bendazac lysine, 2.41g sodium dihydrogen phosphate, 6.61g sodium hydrogen phosphate, 4.2g sodium chloride, adds 200mL water for injection dissolving, but heating for dissolving sometimes after stirring, is settled to 1000mL with water for injection, medicinal liquid.
B. above-mentioned medicinal liquid is with 0.45 μ m filtering with microporous membrane 1 time, 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 two
Prescription:
Its preparation method:
A. precision takes by weighing 5.0g bendazac lysine, 11.2g boric acid, 1.9g Borax, 6.3g glycerol, adds 200mL water for injection dissolving, but heating for dissolving sometimes after stirring, is settled to 1000mL with water for injection, 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 0.5mL seals to 1mL unit dose package plastic containers, gets product.
Embodiment three
Prescription:
Its preparation method:
A. precision takes by weighing 5.0g bendazac lysine, 3.2g sodium dihydrogen phosphate, 5.6g sodium hydrogen phosphate, 12.0g glycerol, adds 200mL water for injection dissolving, but heating for dissolving sometimes after stirring, is settled to 1000mL with water for injection, 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, and it is standby to get solution 1; Precision takes by weighing 5.0g bendazac lysine, 11.6g boric acid, 1.15g Borax, 2.1g sodium chloride, add 200mL water for injection dissolving after, but heating for dissolving sometimes 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. with above-mentioned medicinal liquid with 0.45 μ m filtering with microporous membrane 1 time, 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 five
Prescription:
Its preparation method:
A. precision takes by weighing 5.0g bendazac lysine, 2.41g sodium dihydrogen phosphate, 6.61g sodium hydrogen phosphate, 2.0g glucose, 0.1g ethylenediamine tetrem disodium, add 200mL water for injection dissolving, but heating for dissolving sometimes mixes it, be settled to 1000mL with water for injection, get 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 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. the accurate Carboxymethyl cellulose sodium that takes by weighing 1.6g adds 300mL water for injection and makes it dissolving, and constant temperature stirs for 50～70 ℃ and made it reach sufficient swelling in 14 hours, gets solution; Precision takes by weighing 5.0g bendazac lysine, 3.2g sodium dihydrogen phosphate, 5.6g sodium hydrogen phosphate, 4.2g sodium chloride, 1.0g vitamin C, 0.1g ethylenediamine tetrem disodium, adds in the above-mentioned solution, 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, 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 0.6mL 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 Benzydalysine eye drop of bacteriostatic agent not is characterized in that it comprises following component:
Bendazac lysine 4.5～5.5g
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 Benzydalysine eye drop 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 Benzydalysine eye drop 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 bendazac lysine 4.5～5.5g, 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: 6.8～7.8, mix, 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 Benzydalysine eye drop 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 bendazac lysine 4.5～5.5g, 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: 6.8～7.8, mix, 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 Benzydalysine eye drop of not bacteriostatic agent as claimed in claim 1 or 2, it is characterized in that: the Benzydalysine eye drop 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 Benzydalysine eye drop 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 |
|---|---|---|---|
| CNA2009100736160A CN101455637A (en) | 2009-01-06 | 2009-01-06 | Bendazac lysine eye drops without bacteria inhibitor and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100736160A CN101455637A (en) | 2009-01-06 | 2009-01-06 | Bendazac lysine eye drops without bacteria inhibitor and preparation method thereof |
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| CN101455637A true CN101455637A (en) | 2009-06-17 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622800A (en) * | 2015-02-03 | 2015-05-20 | 吉林修正药业新药开发有限公司 | Bendazac lysine eye drop and preparation method thereof |
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2009
- 2009-01-06 CN CNA2009100736160A patent/CN101455637A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622800A (en) * | 2015-02-03 | 2015-05-20 | 吉林修正药业新药开发有限公司 | Bendazac lysine eye drop and preparation method thereof |
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Open date: 20090617 |