Latanoprost ophthalmic gel, and preparation method therefor, and use thereof

Abstract

A latanoprost ophthalmic gel, comprising the following raw materials: 0.001-0.01% of latanoprost, 0.01-0.1% of a gel matrix, 0.1-5.0% of a nonionic surfactant, 0.1-5.0% of an osmotic pressure regulator, 0.01-1.0% of a pH regulator, and the balance of water for injection. The raw materials do not comprise a bacteriostatic agent. Not adding the bacteriostatic agent can fundamentally eliminate toxic side effects caused by the bacteriostatic agent, avoid adverse reactions to users, and improve product safety; and the non-ionic surfactant can form nanomicelles during the preparation process of the gel to exert a solubilizing effect, so as to overcome the problems of reduced solubility and poor stability of latanoprost caused by the absence of the bacteriostatic agent.

Description

A latanoprost ophthalmic gel and a preparation method and use thereof TECHNICAL FIELD

[0001] The technical scheme of the present application belongs to the technical field of pharmaceutical preparations, and specifically relates to a latanoprost ophthalmic gel and a preparation method and use thereof. BACKGROUND

[0002] Glaucoma is a very common eye disease in clinical, and is commonly seen in the elderly, together with cataract and macular degeneration as the three major blinding eye diseases. The main treatment method for glaucoma is to reduce intraocular pressure until the target intraocular pressure. The mechanism of reducing intraocular pressure is to reduce aqueous humor production and promote aqueous humor outflow.

[0003] Latanoprost is a selective prostaglandin FP receptor agonist, which can reduce intraocular pressure by increasing aqueous humor outflow. Latanoprost eye drops were approved for marketing by the US FDA in 1996, and the trade name is Xalatan, which contains latanoprost 0.005%, benzalkonium chloride 0.02%, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride and water for injection. Among them, benzalkonium chloride not only acts as a bacteriostatic agent, but also helps to dissolve and stabilize latanoprost.

[0004] However, it has been reported that benzalkonium chloride solution can damage corneal epithelial microvilli, thereby reducing tear film stability, reducing conjunctival goblet cell density, indirectly damaging tear film stability, inhibiting the proliferation and activity of corneal epithelial cells, delaying damage repair, or causing squamous metaplasia of corneal epithelium. Benzalkonium chloride is a contact allergen, which can cause delayed hypersensitivity and allergic reactions, and long-term use can cause corneal stromal neurotoxicity damage. Therefore, it is necessary to develop a latanoprost ophthalmic preparation without bacteriostatic agents such as benzalkonium chloride.

[0005] In addition, Xalatan is unstable at room temperature and needs to be stored at 2-8℃ in the dark, which is not convenient for drug storage. Therefore, it is necessary to develop a latanoprost ophthalmic preparation that can be stably stored at room temperature. SUMMARY

[0006] The purpose of the present application is to solve the problems of the existing latanoprost preparations having toxic side effects on the eyes due to the presence of bacteriostatic agents, and the problems of the existing latanoprost preparations being inconvenient to store due to instability at room temperature, and to provide a latanoprost ophthalmic gel and a preparation method and use thereof.

[0007] To achieve the above-mentioned purposes of the application, the technical scheme adopted by the present application is as follows:

[0008] In a first aspect, the present application provides a latanoprost ophthalmic gel, which comprises the following raw materials in terms of mass concentration:

[0009] 0.001-0.01% latanoprost, 0.01-0.1% gel base, 0.1-5.0% non-ionic surfactant, 0.1-5.0% osmotic pressure regulator, 0.01-1.0% pH regulator, and q.s. water for injection; the ingredients not including a bacteriostat.

[0010] In an alternative embodiment, the latanoprost is present in an amount of 0.001-0.005%.

[0011] Alternatively, the latanoprost is present in an amount of 0.001, 0.002, 0.003, 0.004, 0.005, or a range defined by any two of these amounts. Alternatively, the latanoprost is present in an amount of 0.002-0.005%. Illustratively, the latanoprost is present in an amount of 0.005%.

[0012] In an alternative embodiment, the pH of the latanoprost ophthalmic gel is 6.0-8.0; for example, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, or a range defined by any two of these pH values.

[0013] Alternatively, the pH of the latanoprost ophthalmic gel is 6.5-7.5. Illustratively, the pH of the latanoprost ophthalmic gel is 7.0.

[0014] In an alternative embodiment, the gel base comprises at least one of carbomer, gelatin, cellulose, xanthan gum, and sodium alginate. Illustratively, the gel base is carbomer. Illustratively, the gel base is gelatin.

[0015] In an alternative embodiment, the gel base is present in an amount of 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1%, or a range defined by any two of these amounts.

[0016] In an alternative embodiment, the non-ionic surfactant comprises at least one of polyoxyl 40 hydrogenated castor oil, polyoxyl 60 hydrogenated castor oil, polyoxyl 35 castor oil, and polysorbate 80. Illustratively, the non-ionic surfactant is polyoxyl 40 hydrogenated castor oil. Illustratively, the non-ionic surfactant is polyoxyl 35 hydrogenated castor oil.

[0017] In an alternative embodiment, the non-ionic surfactant is present in an amount of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0% or a range of any two of these amounts.

[0018] In an alternative embodiment, the osmotic pressure adjusting agent comprises at least one of glycerin, propylene glycol, mannitol, and sorbitol. Illustratively, the osmotic pressure adjusting agent is glycerin. Illustratively, the osmotic pressure adjusting agent is propylene glycol. Illustratively, the osmotic pressure adjusting agent is mannitol. Illustratively, the osmotic pressure adjusting agent is sorbitol.

[0019] In an alternative embodiment, the osmotic pressure adjusting agent is present in an amount of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0% or a range of any two of these amounts.

[0020] In an alternative embodiment, the pH adjusting agent comprises at least one of sodium hydroxide, potassium hydroxide, and triethanolamine. Illustratively, the pH adjusting agent is sodium hydroxide.

[0021] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost, gelatin as a gel base, polyoxyl 40 hydrogenated castor oil as a non-ionic surfactant, glycerin as an osmotic pressure adjusting agent, sodium hydroxide as a pH adjusting agent, and water for injection, q.s.

[0022] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost 0.001% (w / v), gelatin 0.01% (w / v) as a gel base, polyoxyethylene (40) hydrogenated castor oil 0.1% (w / v) as a non-ionic surfactant, glycerin 0.1% (w / v) as an osmotic pressure adjusting agent, sodium hydroxide 0.01% (w / v) as a pH adjusting agent, and water for injection, q.s.

[0023] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost, carbomer as a gel base, polyoxyethylene (40) hydrogenated castor oil as a non-ionic surfactant, sorbitol as an osmotic pressure adjusting agent, sodium hydroxide as a pH adjusting agent, and water for injection, q.s.

[0024] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost 0.005% (w / v), carbomer 0.1% (w / v) as a gel base, polyoxyethylene (40) hydrogenated castor oil 5.0% (w / v) as a non-ionic surfactant, sorbitol 1.0% (w / v) as an osmotic pressure adjusting agent, sodium hydroxide 1.0% (w / v) as a pH adjusting agent, and water for injection, q.s.

[0025] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost, carbomer as a gel base, polyoxyethylene (35) castor oil as a non-ionic surfactant, mannitol as an osmotic pressure adjusting agent, sodium hydroxide as a pH adjusting agent, and water for injection, q.s.

[0026] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost 0.0025% (w / v), carbomer 0.1% (w / v) as a gel base, polyoxyethylene (35) castor oil 1.0% (w / v) as a non-ionic surfactant, mannitol 3.5% (w / v) as an osmotic pressure adjusting agent, sodium hydroxide 0.5% (w / v) as a pH adjusting agent, and water for injection, q.s.

[0027] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost, carbomer as a gel base, polyoxyethylene (35) castor oil as a non-ionic surfactant, propylene glycol as an osmotic pressure adjusting agent, sodium hydroxide as a pH adjusting agent, and water for injection, q.s.

[0028] In an alternative embodiment, the latanoprost ophthalmic gel comprises: latanoprost 0.005% (w / v), carbomer 0.06% (w / v) as a gel base, polyoxyethylene (35) castor oil 1.0% (w / v) as a non-ionic surfactant, propylene glycol 2.2% (w / v) as an osmotic pressure regulator, sodium hydroxide 0.15% (w / v) as a pH regulator, and the balance of water for injection.

[0029] In a second aspect, the present application provides a preparation method of the above-mentioned latanoprost ophthalmic gel, comprising the following steps:

[0030] S1, dispersing the gel base in water for injection, after sufficient swelling, adding a pH regulator to adjust the pH value, sterilizing to obtain a gel base dispersion;

[0031] S2, dissolving latanoprost in a non-ionic surfactant solution, adding an osmotic pressure regulator, stirring to form uniform micelles, continuing to stir until uniform, sterilizing to obtain a latanoprost dispersion;

[0032] S3, mixing the gel base dispersion and the latanoprost dispersion, adding water for injection to the full amount and mixing evenly.

[0033] In an alternative embodiment, in step S2, the conditions for stirring to form uniform micelles include:

[0034] The stirring speed is 100-1000 rpm, the temperature is 20-50℃, and the time is 5-60 min.

[0035] In a third aspect, the present application provides the use of the above-mentioned latanoprost ophthalmic gel in the preparation of a product for treating glaucoma.

[0036] Based on the above technical solutions, the present application has at least the following beneficial effects:

[0037] The application provides a latanoprost eye gel, which does not contain a bacteriostatic agent and is added with a non-ionic surfactant. In one aspect, the application prepares the latanoprost into an eye gel, and since the eye gel is a single-dose preparation, the bacteriostatic agent does not need to be added, and the addition of the bacteriostatic agent can fundamentally eliminate the toxic side effects of the bacteriostatic agent, avoid adverse reactions to the user, and improve the product safety; in another aspect, the prescription is added with a specific amount of non-ionic surfactant, which can form nanomicelles during the preparation of the gel to play a solubilizing role, so as to overcome the problems of reduced solubility and poor stability of latanoprost due to the absence of the bacteriostatic agent; in still another aspect, the gel has a certain viscosity, which can play a synergistic effect with the nanomicelles formed by the non-ionic surfactant, thereby improving the high-temperature storage stability of the preparation, so that the gel of the application can be stored at room temperature, which is convenient for the use and / or storage of the product. BRIEF DESCRIPTION OF DRAWINGS

[0038] In order to more clearly illustrate the technical solutions in the specific embodiments of the application or the prior art, the attached drawings needed to be used in the description of the specific embodiments or the prior art will be briefly introduced. Obviously, the attached drawings in the following description are some embodiments of the application, and other attached drawings can also be obtained by those skilled in the art without creative labor on the basis of these attached drawings.

[0039] Fig. 1 is a graph of the micellar particle size characterization results of the latanoprost eye gel prepared in Example 1 of the application;

[0040] Fig. 2 is a graph of the micellar freeze transmission electron microscope scanning results of the latanoprost eye gel prepared in Example 1 of the application;

[0041] Fig. 3 is the intraocular pressure monitoring results of SD rats in Example 1 of the application;

[0042] Fig. 4 is the incidence of corneal fluorescein sodium staining positive of SD rats in Example 1 of the application. DETAILED DESCRIPTION

[0043] The following examples are provided to better further understand the application and are not limited to the best mode of the application, and do not limit the content and protection scope of the application. Any person who obtains any product the same as or similar to the application under the inspiration of the application or by combining the application with other prior art features falls within the protection scope of the application.

[0044] The specific experimental steps or conditions are not specified in the examples, and can be performed according to the conventional experimental steps described in the literature in the art or the operation or conditions. The reagents or instruments used are not specified by the manufacturer, and are conventional reagent products that can be obtained by purchase.

[0045] The present application will be further described in conjunction with specific examples which should not be interpreted as limiting the scope of the application.

[0046] Example 1

[0047] The latanoprost ophthalmic gel was prepared according to the following method:

[0048] (1) Each raw material was weighed / measured according to the following formulation: latanoprost 0.001% (w / v), gel base (gelatin) 0.01% (w / v), non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil) 0.1% (w / v), osmotic pressure regulator (glycerol) 0.1% (w / v), pH regulator (sodium hydroxide) 0.01% (w / v), and the balance of water for injection;

[0049] (2) The gel base (gelatin) was dispersed in part of the water for injection, stirred and allowed to stand to swell fully, the pH regulator (sodium hydroxide) was added to adjust the pH to 7.0, sterilized by the wet heat sterilization method, and cooled to room temperature to obtain a gel base dispersion;

[0050] (3) The latanoprost was dissolved in the non-ionic surfactant solution (polyoxyethylene (40) hydrogenated castor oil), the osmotic pressure regulator (glycerol) was added, stirred to form uniform micelles, and stirred to mix uniformly, sterilized by membrane filtration to obtain a latanoprost dispersion;

[0051] (4) The gel base dispersion obtained in step (2) was added to the latanoprost dispersion obtained in step (3), the water for injection was added to the full amount, stirred to mix uniformly, and aseptically filled to obtain the latanoprost ophthalmic gel.

[0052] The latanoprost ophthalmic gel prepared in this example was subjected to micellar particle size characterization and micellar freeze transmission electron microscopy scanning, and the characterization results are shown in FIG. 1 and the scanning results are shown in FIG. 2. As can be seen from FIGS. 1 and 2, the non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil) can form uniform micelles in the gel preparation, which will be beneficial to increase the solubility and stability of latanoprost in the gel preparation.

[0053] Example 2

[0054] The latanoprost ophthalmic gel was prepared according to the following method:

[0055] (1) Weigh / measure each raw material according to the following formula: latanoprost 0.005% (w / v), gel base (carbomer) 0.1% (w / v), non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil) 5.0% (w / v), osmotic pressure regulator (sorbitol) 1.0% (w / v), pH regulator (sodium hydroxide) 1.0% (w / v), and the balance of water for injection;

[0056] (2) Disperse the gel base (carbomer) in part of the water for injection, stir and stand to swell, add the pH regulator (sodium hydroxide) to pH 7.0, sterilize by wet heat, and cool to room temperature to obtain a gel base dispersion;

[0057] (3) Dissolve latanoprost in the non-ionic surfactant solution (polyoxyethylene (40) hydrogenated castor oil), add the osmotic pressure regulator (sorbitol), stir to form uniform micelles, continue to stir to mix uniformly, filter sterilize, and obtain a latanoprost dispersion;

[0058] (4) Add the gel base dispersion obtained in step (2) to the latanoprost dispersion obtained in step (3), add the water for injection to the full amount, stir to mix uniformly, and aseptically fill to obtain a latanoprost eye gel.

[0059] Example 3

[0060] A latanoprost eye gel is prepared according to the following method:

[0061] (1) Weigh / measure each raw material according to the following formula: latanoprost 0.0025% (w / v), gel base (carbomer) 0.1% (w / v), non-ionic surfactant (polyoxyethylene (35) castor oil) 1.0% (w / v), osmotic pressure regulator (mannitol) 3.5% (w / v), pH regulator (sodium hydroxide) 0.5% (w / v), and the balance of water for injection;

[0062] (2) Disperse the gel base (carbomer) in part of the water for injection, stir and stand to swell, add the pH regulator (sodium hydroxide) to adjust the pH to 7.0, sterilize by wet heat, and cool to room temperature to obtain a gel base dispersion;

[0063] (3) Dissolve latanoprost in the non-ionic surfactant solution (polyoxyethylene (35) castor oil), add the osmotic pressure regulator (mannitol), stir to form uniform micelles, continue to stir to mix uniformly, filter sterilize, and obtain a latanoprost dispersion;

[0064] (4) The gel base dispersion solution obtained in step (2) is added to the latanoprost dispersion solution obtained in step (3), and the total amount of water for injection is added. After stirring and mixing, the latanoprost eye gel is obtained by sterile filling.

[0065] Example 4

[0066] The latanoprost eye gel is prepared according to the following method:

[0067] (1) The raw materials are weighed / measured according to the following formulation: latanoprost 0.005% (w / v), gel base (carbomer) 0.06% (w / v), non-ionic surfactant (polyoxyethylene (35) castor oil) 1.0% (w / v), osmotic pressure regulator (propylene glycol) 2.2% (w / v), pH regulator (sodium hydroxide) 0.15% (w / v), and the balance of water for injection;

[0068] (2) The gel base (carbomer) is dispersed in part of the water for injection, stirred and allowed to stand to swell fully. The pH regulator (sodium hydroxide) is added to adjust the pH to 7.0. After sterilization by the wet heat method, the gel base dispersion solution is obtained by cooling to room temperature;

[0069] (3) The latanoprost is dissolved in the non-ionic surfactant solution (polyoxyethylene (35) castor oil), and the osmotic pressure regulator (propylene glycol) is added. After stirring to form uniform micelles, the mixture is stirred and mixed uniformly. The latanoprost dispersion solution is obtained by filtration sterilization.

[0070] (4) The gel base dispersion solution obtained in step (2) is added to the latanoprost dispersion solution obtained in step (3), and the total amount of water for injection is added. After stirring and mixing, the latanoprost eye gel is obtained by sterile filling.

[0071] Comparative Example 1

[0072] The latanoprost eye gel is prepared according to the method of Example 2, except that the amount of non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil) in step (1) of this comparative example is 0.05% (w / v).

[0073] Comparative Example 2

[0074] The latanoprost eye gel is prepared according to the method of Example 2, except that the amount of non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil) in step (1) of this comparative example is 6.0% (w / v).

[0075] Comparative Example 3

[0076] The latanoprost ophthalmic gel was prepared according to the method of Example 2, except that in step (1) of the present comparative example, an equivalent amount of ionic surfactant (sodium dodecyl sulfate) was used to replace the non-ionic surfactant (polyoxyethylene (40) hydrogenated castor oil).

[0077] Experimental Example 1

[0078] Eighteen SD rats with qualified eyes, no abnormality in the anterior segment of the eye, and negative corneal sodium fluorescein staining were selected and randomly divided into five groups, i.e., 2 rats in the normal saline group, 4 rats in the latanoprost solution group (latanoprost 0.005%, benzalkonium chloride 0.02%, disodium hydrogen phosphate 0.474%, sodium dihydrogen phosphate 0.46%, sodium chloride 0.41%, and water for injection to 100%), 4 rats in the 25% latanoprost gel group (latanoprost 0.00125%, gel base (carbomer) 0.06%, non-ionic surfactant (polyoxyethylene (40) castor oil) 5.0%, osmotic pressure regulator (propylene glycol) 0.4%, and pH regulator (sodium hydroxide) 0.15%), 4 rats in the 50% latanoprost gel group (latanoprost 0.0025%, gel base (carbomer) 0.06%, non-ionic surfactant (polyoxyethylene (40) castor oil) 5.0%, osmotic pressure regulator (propylene glycol) 0.4%, and pH regulator (sodium hydroxide) 0.15%), and 4 rats in the 100% latanoprost gel group (latanoprost 0.005%, gel base (carbomer) 0.06%, non-ionic surfactant (polyoxyethylene (40) castor oil) 5.0%, osmotic pressure regulator (propylene glycol) 0.4%, and pH regulator (sodium hydroxide) 0.15%). The ocular toxicity of the drugs to the animals was evaluated by continuous eye drop administration for 6 months. The intraocular pressure was detected before and at 0.5, 1, 2, 3, 4.5, and 6 h after administration on the first day of administration; the corneal sodium fluorescein staining was photographed by slit lamp before and at 1, 2, 3, 4, 5, and 6 months after administration; and other abnormal phenomena of the animals were recorded.

[0079] The results of the intraocular pressure are shown in detail in FIG. 3, and the results show that the solution dosage form has similar intraocular pressure-lowering effect as the gel dosage form. The positive rate (presence of staining on the cornea) of the corneal sodium fluorescein staining results is shown in detail in FIG. 4, and the results show that the positive rate of the solution dosage form is higher than that of the gel dosage form, and the ocular corneal toxicity of the solution dosage form is higher than that of the gel dosage form.

[0080] Experimental Example 2

[0081] The latanoprost ophthalmic gels prepared in Examples 1-4, the latanoprost products prepared in Comparative Examples 1-3, and the commercially available latanoprost eye drops (Xalatan) were subjected to stability investigation, and the investigation items and the investigation results are shown in Table 1.

[0082] Table 1: Stability investigation results of the latanoprost products

[0083] From the results of Example 2 and Comparative Example 1, it can be seen that when the amount of non-ionic surfactant is less than 0.1%, the PDI value increases and the content of latanoprost gradually decreases, indicating that the stability of the gel is poor. From the results of Example 2 and Comparative Example 2, it can be seen that when the amount of non-ionic surfactant is greater than 5%, it can still play a role in improving the stability of the gel, but since the amount of non-ionic surfactant is large, the safety of the gel cannot be guaranteed. From the results of Example 2 and Comparative Example 3, it can be seen that when the non-ionic surfactant in the present application is replaced by an ionic surfactant, the viscosity of the gel is greatly reduced, which does not meet the requirements of the preparation.

[0084] As can be seen from Table 1, the latanoprost ophthalmic gel of the present application has the characteristics of high-temperature storage resistance, and the content of the active ingredient (latanoprost) does not decrease significantly after being stored at 50℃ for 1 month, which indicates that the latanoprost ophthalmic gel of the present application has good high-temperature storage stability.

[0085] The above description is only a preferred specific embodiment of the present application; however, the protection scope of the present application is not limited thereto. Any person skilled in the art, within the technical scope disclosed in the present application, according to the technical solution and improvement concept of the present application, makes equivalent replacement or changes, should be covered in the protection scope of the present application.

Claims

1. A latanoprost ophthalmic gel characterized in that, The latanoprost eye gel includes the following raw materials by mass concentration: 0.001-0.01% of latanoprost, 0.01-0.1% of gel base, 0.1-5.0% of non-ionic surfactant, 0.1-5.0% of osmotic pressure regulator, 0.01-1.0% of pH regulator, and the balance of water for injection; the raw materials do not include bacteriostatic agent.

2. The latanoprost ophthalmic gel of claim 1, wherein, The content of the latanoprost is 0.001-0.005%; Optionally, the content of the latanoprost is 0.002-0.005%.

3. The latanoprost ophthalmic gel of claim 1, wherein, The pH of the latanoprost eye gel is 6.0-8.0; Optionally, the pH of the latanoprost eye gel is 6.5-7.

5.

4. The latanoprost ophthalmic gel of claim 1, wherein, The gel base includes at least one of carbomer, gelatin, cellulose, xanthan gum, and sodium alginate.

5. The latanoprost ophthalmic gel of claim 1, wherein, The non-ionic surfactant includes at least one of polyoxyethylene (40) hydrogenated castor oil, polyoxyethylene (60) hydrogenated castor oil, polyoxyethylene (35) castor oil, and polysorbate 80.

6. The latanoprost ophthalmic gel of claim 1, wherein, The osmotic pressure regulator includes at least one of glycerol, propylene glycol, mannitol, and sorbitol.

7. The latanoprost ophthalmic gel of claim 1, wherein, The pH regulator includes at least one of sodium hydroxide, potassium hydroxide, and triethanolamine.

8. A process for the preparation of latanoprost ophthalmic gel as claimed in any one of claims 1 to 7, characterized in that, The method includes the following steps: S1, dispersing the gel base in water for injection, after sufficient swelling, adding the pH regulator to adjust the pH value, sterilizing to obtain a gel base dispersion; S2, dissolving the latanoprost in the non-ionic surfactant solution, adding the osmotic pressure regulator, stirring to form uniform micelles, continuing to stir until uniform, sterilizing to obtain a latanoprost dispersion; S3, mixing the gel base dispersion with the latanoprost dispersion, adding the water for injection to the full amount and mixing uniformly.

9. The production method according to claim 8, characterized by, In step S2, the conditions for stirring to form uniform micelles include: The stirring speed is 100-1000 rpm, the temperature is 20-50°C, and the time is 5-60 min.

10. Use of the latanoprost eye gel of any one of claims 1-7 in the preparation of a product for treating glaucoma.

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