Gatifloxacin eye drops and preparation method thereof

Abstract

The invention discloses gatifloxacin eye drops and a preparation method of the gatifloxacin eye drops. According to the present invention, the antioxidant in the product is L-cysteine as the natural antioxidant in the body, and the free radical is removed through the reduction reaction so as to achieve the anti-oxidation effect, such that the anti-oxidation effect is provided, the anti-aging effect is provided, the anti-aging effect is good, and the anti-aging effect is good. The situation that the preservative generates chemical reaction at the conjunctiva and the cornea, the conjunctiva and the cornea are damaged, and anaphylactic reaction is caused is avoided; the pearl powder and the natural borneol are added, the pearl powder has the effects of clearing away heat and toxic materials, nourishing the liver and improving eyesight, the natural borneol inhibits release of inflammatory mediators in tissues so as to relieve eye inflammation and red and swollen, and meanwhile, the natural borneol has an analgesic effect by stimulating eye cold receptors, so that eye pain is relieved, and the comfort of a user is improved.

Description

Technical Field

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

[0002] Gatifloxacin eye drops are an ophthalmic medication whose main ingredient is gatifloxacin. It is suitable for acute bacterial conjunctivitis caused by sensitive bacteria. Its main effects and functions are as follows: Gatifloxacin eye drops have a broad-spectrum antibacterial effect against a variety of bacteria, including Gram-positive bacteria, Gram-negative bacteria and anaerobic bacteria. It exerts its antibacterial effect by inhibiting bacterial DNA synthesis; gatifloxacin eye drops have a certain anti-inflammatory effect, which can reduce eye inflammation and relieve symptoms such as eye redness, swelling and pain; gatifloxacin eye drops can improve eye discomfort, such as itching, burning, foreign body sensation, etc., and improve the patient's quality of life. The following points should be noted when using gatifloxacin eye drops: It is contraindicated for those who are allergic to gatifloxacin or other quinolone drugs; it is contraindicated for those with eye trauma or infection; it should be used with caution by pregnant and lactating women; attention should be paid to eye hygiene when using it to avoid cross infection; when dropping the medicine, be careful not to let the bottle mouth touch the eyes to avoid contaminating the medicine; if allergic reactions, eye irritation and other discomfort symptoms occur during use, stop using it immediately and seek medical attention in time.

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

[0004] Traditional gatifloxacin eye drops contain preservatives, such as benzalkonium chloride. Long-term use of preservatives will cause the preservatives in the eyes to produce chemical reactions in the conjunctiva and cornea, damaging the conjunctiva and cornea, leading to allergic reactions, and symptoms such as conjunctival congestion, pain, and itching may occur. Summary of the invention

[0005] The object of the present invention is to provide a gatifloxacin eye drop and a preparation method thereof, so as to solve the problem that the preservatives contained in the traditional gatifloxacin eye drops mentioned in the above background technology, such as benzalkonium chloride, can cause the preservatives in the eyes to produce chemical reactions in the conjunctiva and cornea, damage the conjunctiva and cornea, and lead to the occurrence of allergic reactions, which may cause symptoms such as conjunctival congestion, pain, itching, etc.

[0006] To achieve the above object, the present invention provides the following technical solution: a gatifloxacin eye drop, comprising the following components: by weight, 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate, 10-30 parts of purslane extract, 5-10 parts of pearl powder, 5-10 parts of natural borneol, 5-10 parts of sodium chloride, 5-10 parts of potassium chloride, 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator.

[0007] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 20 parts of gatifloxacin, 25 parts of naphazoline maleate, 25 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 2 parts of osmotic pressure regulator, 3 parts of antioxidant and 5 parts of pH regulator.

[0008] As a preferred technical solution of the present invention, the following are calculated by weight: 30 parts of gatifloxacin, 20 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 2 parts of antioxidant and 5 parts of pH regulator.

[0009] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 35 parts of gatifloxacin, 15 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 4 parts of osmotic pressure regulator, 3 parts of antioxidant and 3 parts of pH regulator.

[0010] As a preferred technical solution of the present invention, the following are the ingredients, by weight: 40 parts of gatifloxacin, 15 parts of naphazoline maleate, 15 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 3 parts of antioxidant and 4 parts of pH regulator.

[0011] As a preferred technical solution of the present invention, the osmotic pressure regulator is polysorbate, sodium edetate and alkonium chloride, the antioxidant is L-cysteine, and the pH regulator is boric acid and borax.

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

[0013] Step 1, preparing the solution for the first time: adding 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate and 10-30 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0014] Step 2, preparing the solution for the second time: adding 5-10 parts of sodium chloride and 5-10 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0015] Step 3, preparing the solution for the third time: adding 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0016] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0017] Step 5, preparing the product: Add 5-10 parts of pearl powder and 5-10 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0018] 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 solution D.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1. The antioxidant in this product is L-cysteine, which is a natural antioxidant in the body. It removes free radicals through reduction reactions, thereby playing an antioxidant role and preventing preservatives from chemically reacting in the conjunctiva and cornea, damaging the conjunctiva and cornea, and causing allergic reactions.

[0021] 2. By adding pearl powder and natural borneol, pearl powder has the effects of clearing away heat and detoxifying, nourishing the liver and improving eyesight, and natural borneol inhibits the release of inflammatory mediators in tissues, thereby reducing eye inflammation and redness and swelling. At the same time, natural borneol stimulates the cold receptors in the eyes to produce analgesic effects, which helps relieve eye pain and improve the user's comfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a flow chart of the present invention. DETAILED DESCRIPTION

[0023] 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.

[0024] Embodiment 1:

[0025] See also Figure 1 The present invention provides a gatifloxacin eye drop, which comprises the following components: by weight, 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate, 10-30 parts of purslane extract, 5-10 parts of pearl powder, 5-10 parts of natural borneol, 5-10 parts of sodium chloride, 5-10 parts of potassium chloride, 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator.

[0026] The osmotic pressure regulators are polysorbate, sodium edetate and alkenium chloride, the antioxidant is L-cysteine, and the pH regulators are boric acid and borax.

[0027] The present invention provides a method for preparing gatifloxacin eye drops, comprising the following steps:

[0028] Step 1, preparing the solution for the first time: adding 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate and 10-30 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0029] Step 2, preparing the solution for the second time: adding 5-10 parts of sodium chloride and 5-10 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0030] Step 3, preparing the solution for the third time: adding 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0031] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0032] Step 5, preparing the product: Add 5-10 parts of pearl powder and 5-10 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0033] 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 solution D.

[0034] Embodiment 2:

[0035] See also Figure 1 The present invention provides a gatifloxacin eye drop, which comprises the following components: by weight, 20 parts of gatifloxacin, 25 parts of naphazoline maleate, 25 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 2 parts of osmotic pressure regulator, 3 parts of antioxidant and 5 parts of pH regulator.

[0036] The osmotic pressure regulators are polysorbate, sodium edetate and alkenium chloride, the antioxidant is L-cysteine, and the pH regulators are boric acid and borax.

[0037] The present invention provides a method for preparing gatifloxacin eye drops, comprising the following steps:

[0038] Step 1, preparing the solution for the first time: adding 20 parts of gatifloxacin, 25 parts of naphazoline maleate and 25 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0039] Step 2, preparing the solution for the second time: adding 5 parts of sodium chloride and 5 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0040] Step 3, preparing the solution for the third time: adding 2 parts of osmotic pressure regulator, 3 parts of antioxidant and 5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0041] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0042] Step 5, preparing the product: Add 5 parts of pearl powder and 5 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0043] 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 solution D.

[0044] Embodiment 3:

[0045] See also Figure 1 The present invention provides a gatifloxacin eye drop, which comprises the following components: by weight, 30 parts of gatifloxacin, 20 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 2 parts of antioxidant and 5 parts of pH regulator.

[0046] The osmotic pressure regulators are polysorbate, sodium edetate and alkenium chloride, the antioxidant is L-cysteine, and the pH regulators are boric acid and borax.

[0047] The present invention provides a method for preparing gatifloxacin eye drops, comprising the following steps:

[0048] Step 1, preparing the solution for the first time: adding 30 parts of gatifloxacin, 20 parts of naphazoline maleate and 20 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0049] Step 2, preparing the solution for the second time: adding 5 parts of sodium chloride and 5 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0050] Step 3, preparing the solution for the third time: adding 3 parts of osmotic pressure regulator, 2 parts of antioxidant and 5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0051] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0052] Step 5, preparing the product: Add 5 parts of pearl powder and 5 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0053] 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 solution D.

[0054] Embodiment 4:

[0055] See also Figure 1 The present invention provides a gatifloxacin eye drop, which comprises the following components: by weight, 35 parts of gatifloxacin, 15 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 4 parts of osmotic pressure regulator, 3 parts of antioxidant and 3 parts of pH regulator.

[0056] The osmotic pressure regulators are polysorbate, sodium edetate and alkenium chloride, the antioxidant is L-cysteine, and the pH regulators are boric acid and borax.

[0057] The present invention provides a method for preparing gatifloxacin eye drops, comprising the following steps:

[0058] Step 1, preparing the solution for the first time: adding 35 parts of gatifloxacin, 15 parts of naphazoline maleate and 20 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0059] Step 2, preparing the solution for the second time: adding 5 parts of sodium chloride and 5 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0060] Step 3, preparing the solution for the third time: adding 4 parts of osmotic pressure regulator, 3 parts of antioxidant and 3 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0061] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0062] Step 5, preparing the product: Add 5 parts of pearl powder and 5 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0063] 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 solution D.

[0064] Embodiment 5:

[0065] See also Figure 1 The present invention provides a gatifloxacin eye drop, which comprises the following components: by weight, 40 parts of gatifloxacin, 15 parts of naphazoline maleate, 15 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 3 parts of antioxidant and 4 parts of pH regulator.

[0066] The osmotic pressure regulators are polysorbate, sodium edetate and alkenium chloride, the antioxidant is L-cysteine, and the pH regulators are boric acid and borax.

[0067] The present invention provides a method for preparing gatifloxacin eye drops, comprising the following steps:

[0068] Step 1, preparing the solution for the first time: adding 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate and 10-30 parts of purslane extract into water for injection and completely dissolving them to obtain solution A;

[0069] Step 2, preparing the solution for the second time: adding 5-10 parts of sodium chloride and 5-10 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B;

[0070] Step 3, preparing the solution for the third time: adding 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C;

[0071] Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D;

[0072] Step 5, preparing the product: Add 5-10 parts of pearl powder and 5-10 parts of natural borneol into solution D and mix thoroughly to obtain the product.

[0073] 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 solution D.

[0074] In the present invention, 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate and 10-30 parts of purslane extract are added to water for injection to completely dissolve them to obtain solution A; 5-10 parts of sodium chloride and 5-10 parts of potassium chloride are added to water for injection to completely dissolve them to obtain solution B; 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator are added to water for injection to completely dissolve them 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 solution D; 5-10 parts of pearl powder and 5-10 parts of natural borneol are put into solution D for full mixing to obtain the product;

[0075] Naphazoline maleate has a significant therapeutic effect on ocular allergic reactions;

[0076] Purslane extract has the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding, dispersing blood stasis and reducing swelling;

[0077] Sodium chloride is an electrolyte supplement used to treat the discomfort caused by hypertonic dehydration, isotonic dehydration and other diseases;

[0078] Potassium chloride is an electrolyte supplement used to treat hypokalemia and also to prevent hypokalemia, thereby replenishing potassium;

[0079] Pearl powder has the effects of clearing away heat and detoxifying, nourishing the liver and improving eyesight;

[0080] Natural borneol inhibits the release of inflammatory mediators in tissues, thereby reducing eye inflammation and redness. At the same time, natural borneol stimulates the cold receptors in the eyes to produce analgesic effects, helping to relieve eye pain.

[0081] 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 gatifloxacin eye drops, characterized in that, The invention comprises the following components: by weight, 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate, 10-30 parts of purslane extract, 5-10 parts of pearl powder, 5-10 parts of natural borneol, 5-10 parts of sodium chloride, 5-10 parts of potassium chloride, 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator.

2. A gatifloxacin eye drops according to claim 1, characterized in that: By weight, the invention comprises 20 parts of gatifloxacin, 25 parts of naphazoline maleate, 25 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 2 parts of osmotic pressure regulator, 3 parts of antioxidant and 5 parts of pH regulator.

3. A gatifloxacin eye drops according to claim 1, characterized in that: In parts by weight, the ingredients include 30 parts of gatifloxacin, 20 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 2 parts of antioxidant and 5 parts of pH regulator.

4. A gatifloxacin eye drops according to claim 1, characterized in that: In parts by weight, the ingredients include 35 parts of gatifloxacin, 15 parts of naphazoline maleate, 20 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 4 parts of osmotic pressure regulator, 3 parts of antioxidant and 3 parts of pH regulator.

5. The gatifloxacin eye drops according to claim 1, characterized in that: In parts by weight, the ingredients include 40 parts of gatifloxacin, 15 parts of naphazoline maleate, 15 parts of purslane extract, 5 parts of pearl powder, 5 parts of natural borneol, 5 parts of sodium chloride, 5 parts of potassium chloride, 3 parts of osmotic pressure regulator, 3 parts of antioxidant and 4 parts of pH regulator.

6. The gatifloxacin eye drops according to claim 1, characterized in that: The osmotic pressure regulator is polysorbate, sodium edetate and alkonium chloride, the antioxidant is L-cysteine, and the pH regulator is boric acid and borax.

7. A method for preparing gatifloxacin 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: adding 20-40 parts of gatifloxacin, 10-40 parts of naphazoline maleate and 10-30 parts of purslane extract into water for injection and completely dissolving them to obtain solution A; Step 2, preparing the solution for the second time: adding 5-10 parts of sodium chloride and 5-10 parts of potassium chloride to water for injection and completely dissolving them to obtain solution B; Step 3, preparing the solution for the third time: adding 1-5 parts of osmotic pressure regulator, 1-5 parts of antioxidant and 1-5 parts of pH regulator to water for injection and completely dissolving them to obtain solution C; Step 4, solution treatment: mixing the prepared solution A, solution B and solution C to obtain solution D; Step 5, preparing the product: Add 5-10 parts of pearl powder and 5-10 parts of natural borneol into solution D and mix thoroughly to obtain the product.

8. The method for preparing gatifloxacin eye drops according to claim 7, 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 solution D.

Images