CN112823784B - Prenoxinate sodium eye drops and solution for ocular administration - Google Patents
Prenoxinate sodium eye drops and solution for ocular administration Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/06—Antiglaucoma agents or miotics
Abstract
The invention provides a pirenoxine sodium eye drop. According to an embodiment of the present invention, the pirenoxine sodium eye drops comprises: a solvent; an anti-inflammatory agent; and a solid preparation containing pirenoxine sodium and pharmaceutically acceptable auxiliary materials. According to the embodiment of the invention, the pirenoxine sodium eye drops simultaneously contain the anti-inflammatory agent and the pirenoxine sodium, so that the pirenoxine sodium eye drops can be applied to eye administration in the early stage of a patient after an operation, can effectively prevent eye infection, can reduce the incidence rate of postoperative capsular opacification, particularly reduce the incidence rate of postoperative capsular opacification after extracapsular cataract extraction, can shorten the healing time of ocular cataract of the patient, also reduce the pain of the patient, and improve the life quality of the patient.
Description
Technical Field
The invention relates to the field of medicines, in particular to pirenoxine sodium eye drops and a solution for ocular administration.
Background
Cataract is the first blindness-causing eye disease in China, and accounts for more than 40 percent of blindness-causing eye diseases. According to the research, one of the reasons for the formation of cataract is due to the fact that soluble proteins in the lens gradually become insoluble proteins under the action of quinones. Quinones are formed by abnormal metabolism of an important functional amino acid (tryptophan) in the body.
The pirenoxine sodium (chemical name: 1-hydroxy-5-oxo-5H-pyrido- [3,2- ] -phenoxazine-3-carboxylic acid sodium) can competitively inhibit the effect of quinone substances on lens soluble proteins, and in addition, the pirenoxine sodium can prevent or treat cataract caused by damage of free radicals to crystalline lens, so the pirenoxine sodium has certain inhibition effect on the development of cataract.
According to animal experimental research, the pirenoxine sodium can reduce the incidence rate of capsular opacification after extracapsular cataract extraction. The pirenoxine sodium eye drops are mainly used for treating early senile cataract, mild diabetic cataract or complicated cataract.
However, the current formulation of pirenoxine sodium remains to be improved.
Disclosure of Invention
The present invention is directed to solving, at least to some extent, one of the technical problems in the related art.
The present invention has been completed based on the following findings of the inventors:
the pirenoxine sodium is usually used as an adjuvant therapy medicament for ophthalmic surgery in the form of eye drops, and the inventor conducts intensive research on the application of the pirenoxine sodium, so that the ophthalmic surgery usually generates ocular or extraocular wounds, and the pirenoxine sodium cannot be used immediately after the surgery in order to prevent infection of patients, but needs to be used after the wounds heal, which increases the probability of postoperative capsular opacification and prolongs the healing time of ocular cataracts of the patients in practice. The inventor of the invention finds that a technical scheme that the combination of the pirenoxine sodium and the anti-inflammatory drug is applied to eyes and can be directly applied to the eyes after operation is provided.
In view of the above, in the first aspect of the present invention, the present invention provides a pirenoxine sodium eye drop. According to an embodiment of the present invention, the pirenoxine sodium eye drops comprises: a solvent; an anti-inflammatory agent; and a solid preparation containing pirenoxine sodium and pharmaceutically acceptable auxiliary materials. According to the embodiment of the invention, the pirenoxine sodium eye drops simultaneously contain the anti-inflammatory agent and the pirenoxine sodium, so that the pirenoxine sodium eye drops can be applied to eye administration in the early stage of a patient after an operation, can effectively prevent eye infection, can reduce the incidence rate of postoperative capsular opacification, particularly reduce the incidence rate of postoperative capsular opacification after extracapsular cataract extraction, can shorten the healing time of ocular cataract of the patient, also reduce the pain of the patient, and improve the life quality of the patient. In addition, considering that the pirenoxine sodium is unstable and easy to degrade in an aqueous solution, the pirenoxine sodium is prepared in a solid preparation and is separated from a solvent, so that the degradation of the pirenoxine sodium can be effectively avoided, and the storage life of the pirenoxine sodium is prolonged.
According to the embodiment of the present invention, the pirenoxine sodium eye drops may further have at least one of the following additional technical features:
according to an embodiment of the invention, the anti-inflammatory agent comprises a corticosteroid. Preferably, the corticosteroid includes at least one selected from the group consisting of triamcinolone, betamethasone, fluocinolone acetonide, hydrocortisone, halomethasone, dexamethasone, and mometasone furoate. More preferably, the corticosteroid is betamethasone or halomethasone. The inventor of the invention unexpectedly finds that the absorption of the pirenoxine sodium can be promoted by adopting the corticosteroid, such as betamethasone or halometasone, so that the absorptivity of the pirenoxine sodium is improved, the synergistic effect is generated with the pirenoxine sodium, the incidence rate of postoperative posterior capsule opacification can be further reduced, particularly the incidence rate of postoperative posterior capsule opacification of extracapsular cataract extraction is reduced, the healing time of the ocular cataract of a patient can be shortened, the pain of the patient is reduced, and the life quality of the patient is improved.
According to an embodiment of the present invention, the mass ratio of the pirenoxine sodium to the anti-inflammatory agent is 1: (0.1-0.3). The inventor finds that the pirenoxine sodium and the anti-inflammatory agent are mixed according to the ratio, so that the effects of resisting inflammation and preventing infection can be effectively exerted when the anti-inflammatory agent is administrated on the eyes after operation, the absorption of the pirenoxine sodium can be effectively promoted, the absorbability of the pirenoxine sodium is improved, and the pirenoxine sodium and the anti-inflammatory agent have synergistic effect.
According to an embodiment of the invention, the anti-inflammatory agent is dissolved in the solvent. The inventor finds that the anti-inflammatory drug can be prepared in a solvent in advance, and the preparation process is simple and convenient to use. According to some embodiments of the invention, the corticosteroid is present in the solvent at a concentration of no more than 0.05% by weight. According to some embodiments of the invention, it is preferred that the solvent comprises: the triamcinolone with a concentration of 0.04-0.05 weight%; the betamethasone at a concentration of 0.04-0.05 wt%; the fluocinonide with the concentration of 0.01-0.02 wt%; hydrocortisone with a concentration of 0.02 to 0.03 wt%; the halometasone at a concentration of 0.01 to 0.02 wt%; dexamethasone with the concentration of 0.003-0.01 wt%; or the mometasone furoate with the concentration of 0.01-0.03 wt%. According to some embodiments of the present invention, it is more preferable that the solvent comprises: the triamcinolone at a concentration of 0.043% by weight; the betamethasone at a concentration of 0.041 wt.%; the fluocinolone acetonide at a concentration of 0.012 wt%; said hydrocortisone at a concentration of 0.026 wt%; the halometasone at a concentration of 0.012 wt.%; said dexamethasone at a concentration of 0.005 weight percent; or said mometasone furoate at a concentration of 0.021 wt%. The inventors have found that the corticosteroid at the above concentration is effective for the prevention of infection and the prevention of inflammation when administered to the eye after surgery, and can effectively promote the absorption of pirenoxine sodium, thereby improving the absorbability of pirenoxine sodium and causing a synergistic effect with pirenoxine sodium. The inventors have also found that the use of a corticosteroid at the above concentration effectively avoids the effect on the pirenoxine sodium eye drop system, and contributes to the improvement in the compatibility between the corticosteroid and the pirenoxine sodium eye drop system.
According to the embodiment of the invention, the pH value of the solvent is 5-7, and the osmotic pressure is 280-320 mOsmol/kg. Therefore, the eye drops can adapt to the physiological environment of eyes, are easy to absorb by the body, and exert the biological activity of the pirenoxine sodium and the anti-inflammatory agent.
According to an embodiment of the invention, the solvent further comprises: 0.1 to 0.5% by weight of potassium chloride; 1 to 3% by weight of boric acid; 0.002 to 0.01 weight percent of borax; and 0.02 to 0.062% by weight of methylparaben. Thus, the aforementioned pH and osmotic pressure can be effectively achieved, and the inventors found that these compounds have compatibility with both corticosteroid and pirenoxine sodium, and thus, the therapeutic effect of pirenoxine sodium eye drops can be improved.
According to an embodiment of the invention, the anti-inflammatory agent is formulated in the solid formulation. According to an embodiment of the present invention, the solid formulation contains, based on the total weight of the solid formulation: the triamcinolone with the content of 8-9 wt%; the betamethasone content is 8-9 wt%; the content of the fluocinolone acetonide is 8-9 wt%; the hydrocortisone with the content of 6-7 wt%; the halometasone in an amount of 4.5 to 5.5 wt%; the dexamethasone with the content of 3-4 wt%; or the mometasone furoate content is 7-8 wt%. According to an embodiment of the present invention, optionally, the solid formulation comprises: the triamcinolone at a content of 8.20% by weight; the betamethasone in an amount of 8.21% by weight; the fluocinolone acetonide in an amount of 8.89 wt%; said hydrocortisone in an amount of 6.28 wt.%; the halometasone in an amount of 5.08 wt%; said dexamethasone in an amount of 3.81 wt.%; or the mometasone furoate in an amount of 7.62 wt%. Therefore, according to the embodiment of the invention, the dispersion degree of the anti-inflammatory agent and the pirenoxine sodium can be effectively improved, the anti-inflammatory and bactericidal effects can be effectively exerted on eyes, the incidence rate of postoperative capsular opacification can be reduced, and particularly the incidence rate of the postoperative capsular opacification of the extracapsular cataract extraction can be reduced.
Since pirenoxine sodium is unstable and easily degraded in an aqueous solution as described above, pirenoxine sodium is formulated in a solid preparation, packaged separately from a solvent, and administered by mixing the solid preparation with the solvent at the time of use. For anti-inflammatory agents, the agent may be placed in the same package as the solvent; or can be placed in the same package with the solid preparation; the medicament can also be independently placed in a package and mixed with a solvent or a solid preparation when in use, and the medicament can be flexibly selected according to the actual situation, and the invention is not strictly limited.
In addition, in a second aspect of the invention, the invention proposes a solution for ocular administration in combination with pirenoxine sodium, which, according to an embodiment of the invention, comprises: a corticosteroid comprising at least one selected from the group consisting of triamcinolone, betamethasone, fluocinolone acetonide, hydrocortisone, halomethasone, dexamethasone, and mometasone furoate. According to the embodiment of the present invention, the solution can be used exclusively for dissolving the solid preparation containing pirenoxine sodium, so that the aforementioned pirenoxine sodium eye drops can be obtained efficiently, and considering that pirenoxine sodium is unstable and easily degraded in an aqueous solution, the pirenoxine sodium can be prepared in the solid preparation and packaged separately from the solution, thereby effectively preventing degradation of pirenoxine sodium and prolonging the shelf life thereof. In addition, it should be noted that the features and advantages described above for pirenoxine sodium eye drops apply equally to the solution for ocular administration in combination with pirenoxine sodium, which is not described in detail here.
According to embodiments of the present invention, the solution for ocular administration in combination with pirenoxine sodium may also have at least one of the following additional technical features:
according to some embodiments of the invention, the corticosteroid is present in the solution at a concentration of no more than 0.05% by weight. According to some embodiments of the invention, it is preferred that the solution comprises: the triamcinolone with a concentration of 0.04-0.05 weight%; the betamethasone at a concentration of 0.04-0.05 wt%; the fluocinonide with the concentration of 0.01-0.02 wt%; hydrocortisone with a concentration of 0.02 to 0.03 wt%; the halometasone at a concentration of 0.01 to 0.02 wt%; dexamethasone with the concentration of 0.003-0.01 wt%; or the mometasone furoate with the concentration of 0.01-0.03 wt%. According to some embodiments of the invention, it is more preferred that the solution comprises: the triamcinolone at a concentration of 0.043% by weight; the betamethasone at a concentration of 0.041 wt.%; the fluocinolone acetonide at a concentration of 0.012 wt%; said hydrocortisone at a concentration of 0.026 wt%; the halometasone at a concentration of 0.012 wt.%; the dexamethasone at a concentration of 0.005 wt%; or said mometasone furoate at a concentration of 0.021 wt%. The inventors have found that the corticosteroid at the above concentration is effective for the prevention of infection and the prevention of inflammation when administered to the eye after surgery, and can effectively promote the absorption of pirenoxine sodium, thereby improving the absorbability of pirenoxine sodium and causing a synergistic effect with pirenoxine sodium. The inventors have also found that the use of a corticosteroid at the above concentration effectively avoids the effect on the pirenoxine sodium eye drop system, and contributes to the improvement in the compatibility between the corticosteroid and the pirenoxine sodium eye drop system.
According to the embodiment of the invention, the pH value of the solution is 5-7, and the osmotic pressure is 280-320 mOsmol/kg. Therefore, the eye drops can adapt to the physiological environment of eyes, are easy to absorb by the body, and exert the biological activity of the pirenoxine sodium and the anti-inflammatory agent.
According to an embodiment of the invention, the solution further comprises: 0.1 to 0.5% by weight of potassium chloride; 1 to 3% by weight of boric acid; 0.002 to 0.01 weight percent of borax; and 0.02 to 0.062 wt% of methyl hydroxybenzoate. Thus, the aforementioned pH and osmotic pressure can be effectively achieved, and the inventors found that these compounds have compatibility with both corticosteroid and pirenoxine sodium, and thus, the therapeutic effect of pirenoxine sodium eye drops can be improved.
Drawings
The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:
FIG. 1 shows a schematic diagram of an analysis of the absorption of a test solution A into aqueous humor of a rabbit eye according to one embodiment of the present invention;
FIG. 2 shows a schematic diagram of an analysis of the absorption of test solution B into aqueous humor of a rabbit eye according to an embodiment of the present invention;
FIG. 3 shows a schematic diagram of an analysis of the absorption of test solution C into aqueous humor of rabbit eyes according to one embodiment of the present invention;
FIG. 4 shows a schematic diagram of an analysis of the absorption of test solution D into aqueous humor of rabbit eyes according to one embodiment of the present invention;
FIG. 5 shows a schematic diagram of an analysis of the absorption of test solution E into aqueous humor of rabbit eyes according to one embodiment of the present invention;
FIG. 6 shows a schematic diagram of an analysis of the absorption of a test solution F into aqueous humor of a rabbit eye according to one embodiment of the present invention;
FIG. 7 shows a schematic diagram of an analysis of the absorption of test solution G into aqueous humor of rabbit eyes according to one embodiment of the present invention.
Detailed Description
The following detailed description of the embodiments of the present invention is intended to be illustrative, and not to be construed as limiting the invention.
General procedure
In the following examples, tablets and solvents (also sometimes referred to herein as "solutions" or "liquids") will be prepared by the following methods, unless otherwise specified.
1. Process for preparing pirenoxine sodium tablets
Raw materials and dosage of pirenoxine sodium tablets:
1.07 parts by weight of pirenoxine sodium;
3.2 parts by weight of ethanol;
16.3 parts by weight of taurine
3.2 parts by weight of boric acid; and
the balance being water (100 parts by weight in terms of total amount).
Injecting 2/3 total volume of water for injection (above 75 deg.C) into a preparation tank, weighing taurine and boric acid, adding into the tank, stirring for 10 min, cooling to 50-60 deg.C, diluting to constant volume, sterilizing by 0.22 μm, filtering to storage tank, and maintaining the temperature at 50-60 deg.C. Then, adjusting the temperature of an air inlet to 160-; meanwhile, dissolving the prescribed amount of pirenoxine sodium in ethanol, mixing with the auxiliary material particles at a total mixing frequency of 50HZ, and pressing under 8.5Mpa to obtain pirenoxine sodium tablet.
2. Method for preparing solution for dissolving pirenoxine sodium tablets
Formulation of the solution for dissolving the pirenoxine sodium tablets:
0.25% by weight potassium chloride;
2.1% by weight of boric acid;
0.063 wt% borax;
0.046% by weight of methylparaben;
a prescribed amount of a corticosteroid (0.043% by weight triamcinolone, 0.041% by weight betamethasone, 0.012% by weight fluocinolone acetonide, 0.026% by weight hydrocortisone, 0.012% by weight halomethasone, 0.005% by weight dexamethasone, or 0.021% by weight mometasone furoate), and
the balance of water.
Adding 70% of injection water (the water temperature is above 70 ℃ before feeding, and stirring is started) into a preparation tank in sequence, adding a prescription amount of methyl hydroxybenzoate into the preparation tank, stirring and dissolving uniformly, then adding prescription amounts of boric acid, borax, potassium chloride and corticosteroid, stirring and dissolving uniformly, heating and boiling for 15 minutes, keeping the temperature for 30 minutes, cooling to 30 ℃, fixing the volume to the preparation full amount, filtering to obtain a solution for dissolving the pirenoxine sodium tablets, wherein the pH value of the solution is 5-7, and the osmotic pressure is 280-320 mOsmol/kg.
Example 1 preparation of a test solution
In this example, a series of solutions for dissolving pirenoxine sodium tablets and pirenoxine sodium tablets were prepared and dissolved by mixing to give a series of test solutions, as follows, according to the method described in the general methods:
(1) test solution A
The weight content ratio of the pirenoxine sodium to the betamethasone is 1: 0.13 (concentration of pirenoxine sodium 0.0053 wt%).
(2) Test solution B
The weight content ratio of the pirenoxine sodium to the hydrocortisone is 1: 0.17 (concentration of pirenoxine sodium 0.0045 wt%).
(3) Test solution C
The weight content ratio of the pirenoxine sodium to the triamcinolone is 1: 0.12 (concentration of pirenoxine sodium 0.0051 wt%).
(4) Test solution D
The weight content ratio of the pirenoxine sodium-fosetyl-flucinonide is 1: 0.29 (concentration of pirenoxine sodium 0.0055 wt%).
(5) Test solution E
Weight content ratio of pirenoxine sodium-halometasone 1: 0.21 (concentration of pirenoxine sodium 0.0050 wt%).
(6) Test solution F
Weight content ratio of pirenoxine sodium-dexamethasone 1: 0.28 (concentration of pirenoxine sodium 0.0032 wt%).
(7) Test solution G
The weight content ratio of the pirenoxine sodium to the furoic acid is 1: 0.14 (concentration of pirenoxine sodium 0.0029 wt%).
EXAMPLE 2 bioavailability assay
"bioavailability" refers to the degree and rate of absorption and utilization of a drug in a target tissue. "Ocular bioavailability" more specifically refers to the concentration of a drug in the aqueous humor following topical administration of the drug comprising the aqueous eye drop composition.
Male albino rabbits of the new zealand white line were used, with one eye topically administered with one of the test solutions a-G and the other eye administered with a reference solution (albuterol), where the concentrations of pirenoxine sodium in solutions a-E were the same as "albuterol" and the concentration of pirenoxine sodium in solution F, G was about 60% of the "albuterol" concentration.
Rabbits were sacrificed at different time points after dosing (5 animals were treated at each time point) and aqueous humor samples were collected. The concentration of pirenoxine sodium was determined using HPLC method. The results of the test solutions A-G are shown in FIGS. 1-7, respectively.
As can be seen in fig. 1-7, the absorption of pirenoxine sodium into the aqueous humor of rabbit eyes in test solutions with different ratios of pirenoxine sodium-corticosteroid was significantly improved compared to "albuterol".
Example 3 postoperative capsular opacification
Injecting 90 male albino rabbits of new zealand white strain with d-galactose 125 mg/kg/day for 42 days, dividing into three groups randomly after forming cataract model, each group containing 30 rabbits, performing extracapsular cataract extraction, wherein the test group is administered with pirenoxine sodium eye drops (weight ratio of pirenoxine sodium to halometasone is 1: 0.13 (concentration of pirenoxine sodium is 0.0053 wt%), instilling 2 times per day, 2-4 drops each time, the comparison group is administered with "BAIDINING" eye drops on the third day after surgery, the comparison group is administered with physiological saline, 10 rabbits of each group are killed in 1, 2 and 3 months, 20 eyes are totally, eyeball specimen is fixed with 10% formaldehyde, artificial lens is taken out, half of eyeball is embedded with paraffin, sliced, hematoxylin-eosin staining, two specimens are made for each eyeball, under an optical microscope, the number of the cells of the posterior capsule membrane of the lens of the HE stained section was measured by using an eyepiece ruler type micrometer, and the test results are shown in Table 1. As can be seen from the table 1, the cell density of the test group is very significantly lower than that of the control group (P is less than 0.01), which indicates that the pirenoxine sodium eye drops provided by the invention are beneficial to reducing the density of the epithelial cells of the posterior capsule membrane of the crystalline lens, and further reducing the probability of postoperative cell proliferation.
TABLE 1 posterior lens capsule epithelial cell density
| Group of | n | 1M | 2M | 3M |
| Test group | 10 | 7.6±1.1* | 6.9±1.2* | 5.2±1.5* |
| Comparison group | 10 | 9.2±1.6 | 8.8±1.4 | 8.1±0.8 |
| Control group | 10 | 10.5±1.2 | 12.6±1.5 | 13.4±1.7 |
P < 0.01 compared to control.
Claims (3)
1. An eye drop solution of pirenoxine sodium, which is characterized by comprising:
a solvent;
an anti-inflammatory agent; and
a solid preparation, which contains pirenoxine sodium and pharmaceutically acceptable auxiliary materials;
the anti-inflammatory agent is selected from betamethasone, and the weight content ratio of the pirenoxine sodium to the betamethasone is 1: 0.13, the concentration of the pirenoxine sodium is 0.0053 wt%; or
The anti-inflammatory agent is selected from halometasone, and the weight content ratio of the pirenoxine sodium to the halometasone is 1: 0.21, the concentration of the pirenoxine sodium is 0.0050 wt%; or
The anti-inflammatory agent is selected from dexamethasone, and the weight content ratio of the pirenoxine sodium to the dexamethasone is 1: 0.28, the concentration of the pirenoxine sodium is 0.0032 weight percent; or
The anti-inflammatory agent is selected from mometasone furoate, and the weight content ratio of the pirenoxine sodium to the mometasone furoate is 1: 0.14, the concentration of the pirenoxine sodium is 0.0029 wt%;
the anti-inflammatory agent is dissolved in the solvent.
2. The pirenoxine sodium eye drop solution according to claim 1, wherein the solvent has a pH of 5 to 7 and an osmotic pressure of 280 to 320 mOsmol/kg.
3. The pirenoxine sodium eye drops according to claim 1, wherein said solvent further comprises:
0.1 to 0.5% by weight of potassium chloride;
1 to 3% by weight of boric acid;
0.002 to 0.01 weight percent of borax; and
0.02 to 0.062% by weight of methylparaben.
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