Pranoprofen eye drops and preparation method thereof

By adding sodium hyaluronate, polyvinyl alcohol, taurine and glucocorticoids to the praprofen eye drops, the problems of eye flora imbalance and aggravation of inflammation in traditional eye drops have been solved, achieving better lubricating, anti-inflammatory and comfortable effects.

CN119970629APending Publication Date: 2025-05-13JIANGSU HANCHEN PHARMA
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Patent Information

Application Number
CN202510176759.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-18
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

Traditional praprofen eye drops contain certain preservatives. Long-term use will lead to normal bacterial dysfunction in the eyes, thereby aggravating the symptoms of eye inflammation, such as dry eyes, pain, and easy fatigue.

Method used

By adding sodium hyaluronate and polyvinyl alcohol to the praprofen eye drops, combined with taurine and glucocorticoids, a new praprofen eye drop is prepared to improve the composition of the praprofen eye drops to reduce the damage to the eye flora.

Benefits of technology

Through the lubricating and anti-inflammatory effects of sodium hyaluronic acid and polyvinyl alcohol, the eye drop reduces eye dryness and inflammation, the heat-clearing and detoxifying effects of taurine and the anti-inflammatory effects of glucocorticoids, and improves the comfort and therapeutic effects of eye drops.

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Abstract

The invention discloses pranoprofen eye drops and a preparation method thereof, and the pranoprofen eye drops are prepared from the following components in parts by weight: 20-30 parts of pranoprofen, 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate, 5-20 parts of polyvinyl alcohol, 5-20 parts of boric acid and 5-20 parts of a surfactant. The sodium hyaluronate and the polyvinyl alcohol are added into the eye drops, and the sodium hyaluronate is a viscoelastic glycoprotein and has lubricating and anti-inflammatory effects; polyvinyl alcohol is artificial tears and is mainly used for treating eye dryness and foreign body sensation caused by xerophthalmia, the situation that due to long-term use, normal flora imbalance of eyes is caused, the symptom of eye inflammation is aggravated, and the experience feeling of a user is improved is avoided; the taurine and the glucocorticoid are added into the eye drops, and the taurine has the effects of clearing away heat and toxic materials and relieving asthenopia, so that the comfort of the eye drops dropped into eyes is improved.
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Description

Technical Field

[0001] The invention relates to the technical field of pranoprofen eye drops, in particular to pranoprofen eye drops and a preparation method thereof. Background Art

[0002] Pranoprofen eye drops are a Western medicine whose main ingredient is pranoprofen. It is commonly used to treat blepharitis, iridocyclitis, conjunctivitis, scleritis, keratitis, etc. This drug is a non-steroidal anti-inflammatory drug that can relieve eye pain and inflammation by inhibiting inflammatory responses. It has a good therapeutic effect, as follows: Pranoprofen eye drops can inhibit the synthesis of prostaglandins, a chemical that plays a role in the inflammatory process. By reducing the production of prostaglandins, it can reduce eye inflammation; due to its anti-inflammatory effect, pranoprofen eye drops can also help relieve eye pain caused by inflammation; pranoprofen eye drops are often used in post-operative care of eye surgery, such as cataract surgery or refractive surgery, to reduce postoperative inflammation and discomfort; it can also be used to treat certain eye diseases, such as conjunctivitis, keratitis, etc., which may be accompanied by inflammation and pain.

[0003] However, traditional pranoprofen eye drops have the following disadvantages:

[0004] Traditional pranoprofen eye drops contain certain preservatives. Long-term use will cause the normal flora of the eye to be imbalanced, thereby aggravating the symptoms of eye inflammation, such as dry eyes, pain, fatigue, etc. Therefore, if the eye drops are used too many times, the symptoms of dry eyes and pain will be further aggravated. Summary of the invention

[0005] The object of the present invention is to provide a pranoprofen eye drops and a preparation method thereof, so as to solve the problem that the traditional pranoprofen eye drops mentioned in the above background technology contain certain preservatives, and long-term use will lead to the imbalance of normal flora of the eye, thereby aggravating the symptoms of eye inflammation, such as dry eyes, pain, fatigue, etc. Therefore, when the eye drops are used too many times, the symptoms of dry eyes and pain will be further aggravated.

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical scheme: a pranoprofen eye drop, comprising the following components: by weight, 20-30 parts of pranoprofen, 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate, 5-20 parts of polyvinyl alcohol, 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant.

[0007] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 2 parts of metal ion complexing agent, 3 parts of antibacterial agent and 5 parts of antioxidant.

[0008] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 1 part of metal ion complexing agent, 4 parts of antibacterial agent and 5 parts of antioxidant.

[0009] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 30 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 10 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 2 parts of antibacterial agent and 5 parts of antioxidant.

[0010] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 25 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 15 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 3 parts of antibacterial agent and 4 parts of antioxidant.

[0011] As a preferred technical solution of the present invention, the surfactant is polysorbate-80, the metal ion complexing agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0012] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0013] Step 1, preparing the solution for the first time: heating water for injection at 60°C, adding 20-30 parts of pranoprofen, and dissolving it completely to obtain solution A;

[0014] Step 2, preparing the solution for the second time: 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate and 5-20 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0015] Step 3, preparing the solution for the third time: 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant are mixed in water for injection to obtain solution C;

[0016] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0017] As a preferred technical solution of the present invention, the mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] 1. Add sodium hyaluronate and polyvinyl alcohol to the eye drops. Sodium hyaluronate is a viscoelastic glycoprotein that plays a lubricating and anti-inflammatory role; polyvinyl alcohol is an artificial tear that is mainly used to treat dry eyes and foreign body sensation caused by dry eyes, to avoid long-term use that will cause the normal flora of the eyes to be imbalanced, thereby aggravating the symptoms of eye inflammation and increasing the user's experience;

[0020] 2. Add taurine and glucocorticoids to the eye drops. Taurine has the effect of clearing away heat and detoxifying, and also has the effect of relieving visual fatigue, and improves the comfort of eye drops when they are dropped into the eyes. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a flow chart of the present invention. DETAILED DESCRIPTION

[0022] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0023] Embodiment 1:

[0024] See also Figure 1 The present invention provides a pranoprofen eye drops, which comprises the following components: by weight, 20-30 parts of pranoprofen, 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate, 5-20 parts of polyvinyl alcohol, 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant.

[0025] The surfactant is polysorbate-80, the metal ion chelating agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0026] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0027] Step 1, preparing the solution for the first time: heating water for injection at 60°C, adding 20-30 parts of pranoprofen, and dissolving it completely to obtain solution A;

[0028] Step 2, preparing the solution for the second time: 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate and 5-20 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0029] Step 3, preparing the solution for the third time: 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant are mixed in water for injection to obtain solution C;

[0030] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0031] The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0032] Embodiment 2:

[0033] See also Figure 1 The present invention provides a pranoprofen eye drops, which comprises the following components: by weight, 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 2 parts of metal ion complexing agent, 3 parts of antibacterial agent and 5 parts of antioxidant.

[0034] The surfactant is polysorbate-80, the metal ion chelating agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0035] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0036] Step 1, preparing the solution for the first time: adding 30 parts of pranoprofen to water for injection at 60°C and dissolving it completely to obtain solution A;

[0037] Step 2, preparing the solution for the second time: 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate and 5 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0038] Step 3, preparing the solution for the third time: 5 parts of boric acid, 5 parts of surfactant, 2 parts of metal ion complexing agent, 3 parts of antibacterial agent and 5 parts of antioxidant are mixed in water for injection to obtain solution C;

[0039] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0040] The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0041] Embodiment 3:

[0042] See also Figure 1 The present invention provides a pranoprofen eye drops, which comprises the following components: by weight, 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 1 part of metal ion complexing agent, 4 parts of antibacterial agent and 5 parts of antioxidant.

[0043] The surfactant is polysorbate-80, the metal ion chelating agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0044] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0045] Step 1, preparing the solution for the first time: adding 30 parts of pranoprofen to water for injection at 60°C and dissolving it completely to obtain solution A;

[0046] Step 2, preparing the solution for the second time: 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate and 5 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0047] Step 3, preparing the solution for the third time: 5 parts of boric acid, 5 parts of surfactant, 1 part of metal ion complexing agent, 4 parts of antibacterial agent and 5 parts of antioxidant are mixed in water for injection to obtain solution C;

[0048] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0049] The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0050] Embodiment 4:

[0051] See also Figure 1 The present invention provides a pranoprofen eye drops, which comprises the following components: by weight, 30 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 10 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 2 parts of antibacterial agent and 5 parts of antioxidant.

[0052] The surfactant is polysorbate-80, the metal ion chelating agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0053] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0054] Step 1, preparing the solution for the first time: adding 30 parts of pranoprofen to water for injection at 60°C and dissolving it completely to obtain solution A;

[0055] Step 2, preparing the solution for the second time: 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate and 5 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0056] Step 3, preparing the solution for the third time: 10 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 2 parts of antibacterial agent and 5 parts of antioxidant are mixed in water for injection to obtain solution C;

[0057] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0058] The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0059] Embodiment 5:

[0060] See also Figure 1 The present invention provides a pranoprofen eye drop, which comprises the following components: by weight, 25 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 15 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 3 parts of antibacterial agent and 4 parts of antioxidant.

[0061] The surfactant is polysorbate-80, the metal ion chelating agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

[0062] The present invention provides a method for preparing pranoprofen eye drops, comprising the following steps:

[0063] Step 1, preparing the solution for the first time: heating water for injection at 60°C, adding 25 parts of pranoprofen, and dissolving it completely to obtain solution A;

[0064] Step 2, preparing the solution for the second time: 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate and 5 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B;

[0065] Step 3, preparing the solution for the third time: 15 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 3 parts of antibacterial agent and 4 parts of antioxidant are mixed in water for injection to obtain solution C;

[0066] Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

[0067] The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.

[0068] In the present invention, 20-30 parts of pranoprofen are added to injection water at 60° C. to completely dissolve the pranoprofen to obtain solution A; 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate and 5-20 parts of polyvinyl alcohol are uniformly mixed in the injection water to obtain solution B; 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant are uniformly mixed in the injection water to obtain solution C; after filtering impurities through a filter membrane, solution A, solution B and solution C are respectively put into a constant volume device for constant volume, and the constant volume solution B and solution C are put into a mixing device together for full mixing to obtain a product;

[0069] Taurine has the effect of clearing away heat and detoxifying, and can also relieve visual fatigue;

[0070] Sodium hyaluronate is a viscoelastic glycoprotein that plays a lubricating and anti-inflammatory role;

[0071] Polyvinyl alcohol is an artificial tear that is mainly used to treat dry eyes and foreign body sensation caused by dry eyes;

[0072] Glucocorticoids are effective drugs for controlling non-infectious inflammation of the external eye and anterior segment of the eye and for reducing inflammatory reactions after cataract surgery. Glucocorticoids are effective drugs for controlling non-infectious inflammation of the external eye and anterior segment of the eye and for reducing postoperative reactions, but long-term local application in the eyes can produce hormonal cataracts and hormonal glaucoma, and large-scale systemic use of corticosteroids can induce fungal and herpetic keratitis, delay the repair of corneal trauma, and even cause corneal perforation.

[0073] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A pranoprofen eye drop, characterized in that, The invention comprises the following components: by weight, 20-30 parts of pranoprofen, 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate, 5-20 parts of polyvinyl alcohol, 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant.

2. A pranoprofen eye drop according to claim 1, characterized in that: In parts by weight, the ingredients include 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 2 parts of metal ion complexing agent, 3 parts of antibacterial agent and 5 parts of antioxidant.

3. A pranoprofen eye drop according to claim 1, characterized in that: In parts by weight, the ingredients include 30 parts of pranoprofen, 30 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 5 parts of boric acid, 5 parts of surfactant, 1 part of metal ion complexing agent, 4 parts of antibacterial agent and 5 parts of antioxidant.

4. A pranoprofen eye drop according to claim 1, characterized in that: In parts by weight, the ingredients include 30 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 10 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 2 parts of antibacterial agent and 5 parts of antioxidant.

5. A pranoprofen eye drop according to claim 1, characterized in that: In parts by weight, the ingredients include 25 parts of pranoprofen, 25 parts of glucocorticoid, 5 parts of taurine, 5 parts of glucose, 5 parts of sodium hyaluronate, 5 parts of polyvinyl alcohol, 15 parts of boric acid, 5 parts of surfactant, 3 parts of metal ion complexing agent, 3 parts of antibacterial agent and 4 parts of antioxidant.

6. The pranoprofen eye drops according to claim 1, characterized in that: The surfactant is polysorbate-80, the metal ion complexing agent is sodium edetate, the antibacterial agent is salkonium chloride, and the antioxidant is di-tert-butyl-p-cresol.

7. A method for preparing pranoprofen eye drops according to any one of claims 1 to 6, characterized in that: The following steps are involved: Step 1, preparing the solution for the first time: heating water for injection at 60°C, adding 20-30 parts of pranoprofen, and dissolving it completely to obtain solution A; Step 2, preparing the solution for the second time: 20-30 parts of glucocorticoid, 5-20 parts of taurine, 5-20 parts of glucose, 5-20 parts of sodium hyaluronate and 5-20 parts of polyvinyl alcohol are mixed in water for injection to obtain solution B; Step 3, preparing the solution for the third time: 5-20 parts of boric acid, 5-20 parts of surfactant, 1-5 parts of metal ion complexing agent, 1-5 parts of antibacterial agent and 1-5 parts of antioxidant are mixed in water for injection to obtain solution C; Step 4: Solution treatment: The prepared solution A, solution B and solution C are mixed to obtain a product.

8. A pranoprofen eye drop and a preparation method thereof according to claim 1, characterized in that: The mixing treatment in step 4 is specifically as follows: after filtering impurities through filter membranes, solution A, solution B and solution C are respectively placed in a constant volume device for constant volume, and the constant volume solution B and solution C are placed together in a mixing device for full mixing to obtain a product.