CN102512362B - Formula and preparation method of compound ciprofloxacin eye drops - Google Patents
Formula and preparation method of compound ciprofloxacin eye drops Download PDFInfo
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- CN102512362B CN102512362B CN 201110431897 CN201110431897A CN102512362B CN 102512362 B CN102512362 B CN 102512362B CN 201110431897 CN201110431897 CN 201110431897 CN 201110431897 A CN201110431897 A CN 201110431897A CN 102512362 B CN102512362 B CN 102512362B
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Abstract
The present invention discloses a formula and a preparation method of compound ciprofloxacin eye drops, the formula takes ciprofloxacin and borneol as basic components, a solubilizer, a thickening agent, a preservative, an isotonic regulator, a PH regulator and sterile water for injection are supplemented to prepare the ophthalmic preparation. The borneol is added for the eye drops in the invention on the basis of the ciprofloxacin ophthalmic preparation, the eye drops possess multiple functions of resisting bacterial and diminishing inflammation, relieving swelling and pain, and cooling and relieving itching.
Description
Technical field
The present invention relates to prescription and the preparation method of kind of a kind of compound ciprofloxacin eye drop.
Background technology
Disposable levofloxacin hydrochloride eye drops tool broad-spectrum antibacterial action, at present disposable levofloxacin hydrochloride eye drops is used for responsive microbial outer eye infection (as conjunctivitis etc.).
Disposable levofloxacin hydrochloride eye drops has the middle part to stimulate through long-term clinical application reaction to eye, and it is excessive that concentration is accumulated by frequent eye dripping eye topical remedy, the damage maximum of corneal.With the prolongation of administration time and the reinforcement of toxic degree, the degree of pathological changes and scope are strengthened, medicament for the eyes can cause in the part dose dependent cytotoxic effect [list of references: Yang Xiaohui. the clinical analysis of medicine keratopathy. international ophthalmology magazine 2007; 7 (3): 861,862].
The present invention has increased Borneolum Syntheticum in disposable levofloxacin hydrochloride eye drops.Borneolum Syntheticum has removing nebula and makes eye bright, the effect of reducing swelling and alleviating pain.Borneolum Syntheticum has the antiviral pharmacotoxicological effect of antiinflammatory on the one hand, and Borneolum Syntheticum can increase the corneal permeability of other medicines on the other hand, is a kind of very promising penetration enhancer.Borneolum Syntheticum can promote the ocular absorption of No. one, TCM Ophthalmology medicine for external use virus.Borneolum Syntheticum can make the phospholipid bilayer motion of corneal epithelial cells of rabbit film more orderly, thereby increase the permeability [list of references: Wu CJ of corneal epithelial cell, Huang QW, Qi HY, et al.Promoting effect of borneol on the permeability of puerarin eye drops and timolol maleate eye drops through the cornea in vitro.Pharmazie2006; 61 (9): 783,788 and Fan Lanlan, Tang is by it, Lu Jingfen, etc. Borneolum Syntheticum is to the short chemosmotic experimentation of corneal epithelial cells of rabbit film. Chinese TCM Ophthalmology magazine 1998; 8 (2): 67,69].
Through experiment confirm, the Borneolum Syntheticum eye drop of eye prolonged application 0.25～1g/L concentration increases to some extent with the increase eye table zest scoring of concentration, and eye is shown equal nonirritant.Can not produce pathologic lesion to the cornea that is easy to generate drug accumulation yet, other each tissue of ophthalmic is not all had dealed with medicine went as iris, retina, optic nerve.
Summary of the invention
[0005] the object of the present invention is to provide and a kind ofly infect (as conjunctivitis etc.) and can effectively alleviate eye drip to the stimulation of eye for the microbial outer eye of sensitivity, and increase pharmaceutical formulation and the preparation method of the corneal permeability symptom of other medicines.
For achieving the goal, the present invention is achieved by the following technical solutions:
A kind of compound ciprofloxacin eye drop of the present invention, it comprises following component:
All the other are solvent.
Wherein, described isotonic agent is that in sodium chloride, potassium chloride, boric acid, sodium sulfate, Chile saltpeter, potassium nitrate, sodium acetate, mannitol, glycerol, propylene glycol, the glucose one or more are composite.
Described PH regulator is that in phosphoric acid dichloro sodium, sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, boric acid, Borax, 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 stabilizing agent be sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium nitrite, sodium thiosulfate, ascorbic acid (vitamin C), thiourea, ascorbyl stearate, dibutyl hydroxy toluene, cysteine, disodiumedetate (EDTA-2Na, disodium edetate), calcio-disodium edetate, dimercaptopropanol, BAL, glycerol, mannitol, in one or more are composite;
Described thickening agent is that in hyaluronate sodium, chondroitin sulfate, methylcellulose, hypromellose, hydroxypropyl methylcellulose, cellulose, polyvidone, polyvinylpyrrolidone, polyvinyl alcohol, the carbomer one or more are composite;
Described solubilizing agent is a kind of in ethanol, tween, glycerol, propylene glycol, the Polyethylene Glycol.
Described antiseptic is benzalkonium bromide solution.
Solvent is water for injection.
Preferred compound ciprofloxacin eye drop of the present invention, each component is as follows:
All the other are solvent.
Most preferred compound ciprofloxacin eye drop of the present invention, each component is as follows:
Ciprofloxacin (in ciprofloxacin) 30.0g
All the other are solvent.
The present invention also provides the preparation method of compound ciprofloxacin eye drop, and its preparation process is as follows:
With the water for injection of 200～400ml of about amount of preparation, put into Agitation Tank.
Ciprofloxacin is placed stainless steel cask, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Stabilizing agent, isotonic agent are placed enamel pan, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Water for injection with 150～300ml places the enamel ingredients pot, slowly adds thickening agent, stirs, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank.
With antiseptic, add an amount of water for injection, suck Agitation Tank.
Solubilizing agent is placed the enamel ingredients pot, add Borneolum Syntheticum, add an amount of water for injection, pour Agitation Tank into, add an amount of water for injection near 1000ml.
Regulate PH with PH regulator 1, cooling.Medicinal liquid behind 0.22～0.45um filtering with microporous membrane 1～5 time, fill.
Prescription of the present invention is formed through screening, and screening process is as follows:
1, the adjustment of viscosity
The suitable viscosity of eye drop is between 4.0～5.0mPas, and using this hydrophilic high molecular material of hypromellose increases solution viscosity, can reduce loss, prolong drug and cornea time of contact, is conducive to drug osmotic.
2, the adjustment of PH
PH value has very significant effects to eye drop, and the inappropriate meeting of pH value causes stimulation to eye, increases lacrimal secretion, causes medicine to run off rapidly, even the damage eye mask.The pH value that normal eye can tolerate is 5.0～9.0, numbness when pH value is 6.0～8.0, and less than 5.0 with all tangible sensation can be arranged greater than 11.0 o'clock, in order to alleviate sense of discomfort as far as possible, ophthalmic solution should have the pH value identical with tear.The present invention adjusts PH7.0～8.0 with hydrogen sodium sodium.
3, the adjusting of osmotic pressure
The osmotic pressure of ophthalmic solution should be tried one's best and wave equates that the osmotic pressure of tear is 7.4 atmospheric pressure.Hyperosmotic solution makes cornea dry out within the eye, makes the tissue drying and the uncomfortable sensation of generation; Hypisotonic solution can make the cornea tissue cell swell and produce stimulation.The too high or too low eye that also can stimulate of solution osmotic pressure increases tear, causes medicinal liquid dilution or loss rapidly, and therefore general ophthalmic solution all should be regulated its osmotic pressure.Eyes than blood height, can tolerate the osmotic pressure scope that is equivalent to 0.5%～2.0% sodium chloride solution to the toleration of osmotic pressure.Most of people are acceptables in the scope of 0.7%～1.5% sodium chloride, so the osmotic pressure scalable of ophthalmic solution is in this scope.
4, the maintenance of sterility
As the antibacterial of eye drop, not only require effectively, also to have lower toxicity, water soluble.With benzalkonium bromide in the antibacterial that meets these requirements, nontoxic, non-stimulated, stable in properties, fast light, heat-resisting, non-volatility, but long-term storage.
5, stabilizing agent determines
Disodium edetate is widely used in eye drop, and low toxicity is water-soluble, and has coordination property widely, almost can form stable chelate with all metal ions, makes product more stable.
6, solubilizing agent determines
The effect of solubilizing agent is to increase the dissolubility of Borneolum Syntheticum in water, Borneolum Syntheticum tool volatility, and easily distillation is almost insoluble in water.Tween 80 is high to the dissolubility of Borneolum Syntheticum, and also easily molten in water, and tween content under these conditions is harmless to human body.
The present invention also provides assay, stability test, toxicity test and the irritation test result of said preparation, and is specific as follows:
1, assay
The hydrochloric ciprofloxacin of this product should be 90%～110% of labelled amount
2, stability test
This product is through simulation listing packing, places 6 months and keeps sample for a long time under 40 ℃, relative humidity 75% condition and investigate 18 months, every investigation index and relatively do not have significant change in 0 day.
Conclusion: this product is tested through the influence factor, and accelerated test and room temperature are investigated 18 months, and the result shows: every index does not have obvious variation.This product should place below 25 ℃ and preserve, and it is 2 years that effect duration can fix tentatively.This product preparation technology is convenient feasible, quality controllable.
3, toxicity test:
Material: compound hydrochloric acid ciprofloxacin eye drop, 0.9% normal saline.Healthy white rabbit, 20, male and female are regardless of, quality 2.5～2.8kg.24h before experiment beginning 20g/L fluorescein sodium corneal dyeing.
Test method: 8 white rabbit are divided into 2 groups at random, 4 every group.The 1st group all drips reagent.The 2nd group drips normal saline and does own control.Medication will be splashed in the conjunctival sac by reagent 50 μ L for drawing back the palpebra inferior of rabbit eyes gently, make the passive closed 3s of upper and lower eyelid, to prevent lost by the reagent thing.After the administration 1,2,4,24,48, the irritant reaction of 72h and 7d slit lamp observation eye drop corneal, iris and conjunctiva.Standards of grading by the eye irritant reaction in each the inspection record integration.The irritant reaction score value addition of cornea, iris and conjunctiva of each animal gets total mark observing time with each, and one group integration summation divided by number of animals, is namely got last score value.0～3 fen nonirritant, 4～8 fens slight zests, 9～12 fens moderate zests, 13～16 fens intensity zests.
Experiment confirm, the scoring of two groups of irritant reaction all＜3 minutes, eye is shown equal nonirritant.Can not produce pathologic lesion to the cornea that is easy to generate drug accumulation yet, other each tissue of ophthalmic is not all had dealed with medicine went as iris, retina, optic nerve.
Long term toxicity test: 12 white rabbit are divided into 3 groups at random, 4 every group.1 group of blank group, 2 groups of normal saline matched groups, 3 groups of same irritant experiments of compound hydrochloric acid ciprofloxacin eye drop group medication.4 times/d, continuous 4wk.During 28d behind the last eye dripping auricular vein get blood 6mL, make routine blood test and blood biochemistry respectively.
Long term toxicity test can disclose dosage poisonous effect relation, toxicity target organ, nontoxic amounts of reactants and the safety range of medicine.Every index of routine blood test and blood biochemistry changes in the blood parameters analysis all its certain sense: anemia, hemorrhage and haemolysis can cause that RBC descends; Anemia can cause that HGB descends; Bone marrow depression can cause PLT to reduce; Bacterial infection and bone marrow stimulate can cause the WBC rising.ALT is the liver function sensitive indicator, is most commonly used to evaluating liver infringement or hepatic disease; AST mainly is present in skeletal muscle and the cardiac muscle, and normal relevant with the infringement of these tissues; TP and ALB can reduce when malnutrition or hepatic and renal function long-term damage; BUN and Cr are the indexs of assessment kidney blood filtration ability, and Cr has more specificity than BUN.In a word, blood routine and biochemical indicator can reflect potential target organ damage.Dirty body has also illustrated the influence degree of dealed with medicine went to a certain extent than the result of coefficient except the blood parameter.
In this experiment, more than three groups blood routine compare with matched group with biochemical indicator and do not have significant difference, the dirty body of each experimental group does not have significance than difference of coefficients.Above-mentioned experimental result can think that eye prolonged application compound hydrochloric acid ciprofloxacin eye drop does not have influence to the function of organization of internal organs such as blood system and Liver and kidney.
4, synergism contrast experiment: material: compound hydrochloric acid ciprofloxacin eye drop, disposable levofloxacin hydrochloride eye drops (component is except Borneolum Syntheticum, Tween 80), Borneolum Syntheticum eye drop (component demineralizing acid ciprofloxacin).Healthy white rabbit, 18, male and female are regardless of, quality 2.5～2.8kg.24h before experiment beginning 20g/L fluorescein sodium corneal dyeing.
Test method: 18 white rabbit are divided into 3 groups at random, 6 every group.The 1st group drips compound hydrochloric acid ciprofloxacin eye drop.The 2nd group drips disposable levofloxacin hydrochloride eye drops.The 3rd group drips the Borneolum Syntheticum eye drop.Medication will be splashed in the conjunctival sac by reagent 50 μ L for drawing back the palpebra inferior of rabbit eyes gently, make the passive closed 3s of upper and lower eyelid, to prevent lost by the reagent thing.After the administration 1,2,4,24,48, the irritant reaction of 72h and 7d slit lamp observation eye drop corneal, iris and conjunctiva.Standards of grading by the eye irritant reaction in each the inspection record integration.The irritant reaction score value addition of cornea, iris and conjunctiva of each animal gets total mark observing time with each, and one group integration summation divided by number of animals, is namely got last score value.0～3 fen nonirritant, 4～8 fens slight zests, 9～12 fens moderate zests, 13～16 fens intensity zests.
Experiment confirm, the scoring of first group of irritant reaction all＜3 minutes, to eye table nonirritant; Second group of irritant reaction scoring had slight zest to the eye table between 3～5 minutes; The scoring of the 3rd group of irritative response all＜3 minutes, to eye table nonirritant.Three groups of tests show that the synergism of compound hydrochloric acid ciprofloxacin eye drop strengthens, and reduces the zest of medicine.
The specific embodiment:
Embodiment 1
With the water for injection of about 200ml, put into Agitation Tank.
Ciprofloxacin 30.0 is placed stainless steel cask, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Disodium edetate 1g, sodium chloride 70g are placed enamel pan, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Water for injection with 150～300ml places the enamel ingredients pot, slowly adds hypromellose 30g, stirs, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank.
Benzalkonium bromide 20ml with 5% adds an amount of water for injection, sucks Agitation Tank.
With Tween 80,3g places enamel pan, adds Borneolum Syntheticum 1g again, adds an amount of water for injection, pours Agitation Tank into, adds an amount of water for injection near 1000ml.
Sodium hydroxide 40ml～50ml with 1mol/L regulates PH, cooling.Medicinal liquid behind 0.22～0.45um filtering with microporous membrane 1～5 time, fill.
Embodiment 2
With the water for injection of about 200ml, put into Agitation Tank.
Ciprofloxacin 30.0 is placed stainless steel cask, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Disodium edetate 1g, sodium chloride 80g are placed enamel pan, after the water for injection dissolving of about 100～200ml of usefulness configuration amount, suck Agitation Tank.
Water for injection with 150～300ml places the enamel ingredients pot, slowly adds hypromellose 28g, stirs, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank.
Benzalkonium bromide 18ml with 5% adds an amount of water for injection, sucks Agitation Tank.
With Tween 80,4g places enamel pan, adds Borneolum Syntheticum 1g again, adds an amount of water for injection, pours Agitation Tank into, adds an amount of water for injection near 1000ml.
Sodium hydroxide 40ml～50ml with 1mol/L regulates PH, cooling.Medicinal liquid behind 0.22～0.45um filtering with microporous membrane 1～5 time, fill.
Claims (5)
1. a compound ciprofloxacin eye drop is characterized in that, each set of dispense is such as following:
All the other are water for injection.
2. according to the eye drop of claim 1, it is characterized in that each set of dispense is such as following:
All the other are water for injection.
3. according to the eye drop of claim 1, it is characterized in that each set of dispense is such as following:
Preparation technology:
(1) with the water for injection of 200ml, puts into Agitation Tank;
(2) ciprofloxacin 30.0 g are placed stainless steel cask, after the water for injection dissolving with 100 ~ 200ml, suck Agitation Tank;
(3) disodium edetate 1g, sodium chloride 70g are placed enamel pan, after the water for injection dissolving with 100 ~ 200ml, suck Agitation Tank;
(4) water for injection with 150 ~ 300ml places the enamel ingredients pot, slowly adds hypromellose 30g, stirs, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank;
(5) with 5% benzalkonium bromide 20ml, add an amount of water for injection, suck Agitation Tank;
(6) the 3g Tween 80 is placed enamel pan, add Borneolum Syntheticum 1g again, add an amount of water for injection, pour Agitation Tank into, add an amount of water for injection near 1000ml;
(7) regulates pH with sodium hydroxide 40ml ~ 50ml of 1mol/L, cools off, medicinal liquid behind 0.22 ~ 0.45 μ m filtering with microporous membrane 1 ~ 5 time, fill.
4. according to the eye drop of claim 1, it is characterized in that each set of dispense is such as following:
Preparation technology:
(1) with the water for injection of 200ml, puts into Agitation Tank;
(2) ciprofloxacin 30.0 is placed stainless steel cask, after the water for injection dissolving with 100 ~ 200ml, suck Agitation Tank;
(3) disodium edetate 1g, sodium chloride 80g are placed enamel pan, after the water for injection dissolving with 100 ~ 200ml, suck Agitation Tank;
(4) water for injection with 150 ~ 300ml places the enamel ingredients pot, slowly adds hypromellose 28g, stirs, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank;
(5) with 5% benzalkonium bromide 18ml, add an amount of water for injection, suck Agitation Tank;
(6) the 4g Tween 80 is placed enamel pan, add Borneolum Syntheticum 1g again, add an amount of water for injection, pour Agitation Tank into, add an amount of water for injection near 1000ml;
(7) regulates pH with sodium hydroxide 40ml ~ 50ml of 1mol/L, cools off, medicinal liquid behind 0.22 ~ 0.45 μ m filtering with microporous membrane 1 ~ 5 time, fill.
5. the preparation method of the described eye drop of claim 1 is characterized in that, may further comprise the steps:
A, with the water for injection of 200ml, put into Agitation Tank;
B, ciprofloxacin 26 ~ 35g is placed stainless steel cask, after the water for injection dissolving with 100 ~ 200ml, suck Agitation Tank;
C, disodium edetate 0.01g ~ 5g, sodium chloride 0.1 ~ 80g are placed enamel pan, after the water for injection dissolving with 100 ~ 200ml of configuration amount, suck Agitation Tank;
D, place the enamel ingredients pot with the water for injection of 150 ~ 300ml, slowly add hypromellose 1g ~ 50g, stir, boil swelling after, be cooled to below 60 ℃, put into the mixer weighing, suck Agitation Tank;
E, the benzalkonium bromide 1ml ~ 30ml with 5% add an amount of water for injection, suck Agitation Tank;
F, Tween 80 1g ~ 10g is placed the enamel ingredients pot, add Borneolum Syntheticum 0.9 ~ 1.1g, add an amount of water for injection, pour Agitation Tank into, add an amount of water for injection near 1000ml;
G, regulates pH with sodium hydroxide 1ml ~ 50ml of 1mol/L, cools off, medicinal liquid behind 0.22 ~ 0.45 μ m filtering with microporous membrane 1 ~ 5 time, fill.
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| WO2003015752A1 (en) * | 2001-08-14 | 2003-02-27 | Bakulesh Mafatlal Khamar | The process for preparing isotonic topical antibiotic ophthalmic formulation with improved therapeutic effect |
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| CN1785192A (en) * | 2004-12-08 | 2006-06-14 | 胡世兴 | Eye-drops prepns. contg. tetrandrine and its application for preparing medicine therewith |
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Address after: 214028 Changjiang South Road, new Wu District, Wuxi, Jiangsu Province, No. 12 Co-patentee after: JINGXI JIMIN KEXIN GROUP Co.,Ltd. Patentee after: Wuxi Jiyu Shanhe Pharmaceutical Co., Ltd Address before: 214028 No. 12 Changjiang South Road, New District, Jiangsu, Wuxi Co-patentee before: JINGXI JIMIN KEXIN GROUP Co.,Ltd. Patentee before: WUXI JIMIN KEXIN SHANHE PHARMACEUTICAL Co.,Ltd. |
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