A contact lens compound care solution and a preparation method thereof

Abstract

This invention belongs to the technical field of eye care products, specifically relating to a compound contact lens care solution and its preparation method. The compound contact lens care solution provided by this invention, based on a total mass of 1000 parts, comprises: 0.2-14 parts of a moisturizing composition, 0.001-0.005 parts of a preservative, 6-10 parts of a buffer, 1-6 parts of an osmotic pressure regulator, 0.1-1 parts of a chelating agent, and the balance being water; the moisturizing composition consists of sodium hyaluronate, propylene glycol, and ectoine. This invention, through the compounding of sodium hyaluronate, propylene glycol, and ectoine into a moisturizing composition, reduces the irritation to the eyes caused by contact lenses and care solution components in terms of moisturizing, water retention, and cell protection, alleviating dryness and discomfort, and improving eye wearing comfort.

Description

Technical Field

[0001] This invention belongs to the field of eye care products technology, specifically relating to a compound contact lens care solution and its preparation method. Background Technology

[0002] Prolonged contact lens wear can easily lead to dry eyes and reduced comfort. Current contact lens care products fall short in their systematic integration of immediate lubrication, moisture retention, and cellular protection. There is an urgent need for a contact lens care product that can address discomfort from multiple perspectives, including physical lubrication, moisture retention, and cellular protection. Summary of the Invention

[0003] The purpose of this invention is to provide a compound contact lens care solution and its preparation method. The compound contact lens care solution provided by this invention integrates instant lubrication, water-locking and cell protection functions, which can improve the wearing comfort of contact lenses.

[0004] To achieve the above objectives, the present invention provides the following technical solution: A compound contact lens care solution, based on a total mass of 1000 parts, comprises: 0.2-14 parts of a moisturizing composition, 0.001-0.005 parts of a preservative, 6-10 parts of a buffer, 1-6 parts of an osmotic pressure regulator, 0.1-1 parts of a chelating agent, and the balance being water; the moisturizing composition comprises sodium hyaluronate, propylene glycol, and ectoine.

[0005] Preferably, the components of the moisturizing composition, by mass parts, are: 0.01-2 parts sodium hyaluronate, 0.1-6 parts propylene glycol, and 0.1-6 parts ectoine.

[0006] Preferably, the components of the moisturizing composition, by weight parts, are: 0.05-0.8 parts sodium hyaluronate, 0.5-5 parts propylene glycol, and 0.5-5 parts ectoine.

[0007] Preferably, the preservative is one or more of polyhexamethylene biguanide, polyquaternium salt, and sodium chlorite.

[0008] Preferably, the buffer is one or more of sodium dihydrogen phosphate-disodium hydrogen phosphate, tromethamine-hydrochloric acid, and boric acid-borax.

[0009] Preferably, the osmotic pressure regulator is sodium chloride and / or potassium chloride.

[0010] Preferably, the chelating agent is one or both of disodium ethylenediaminetetraacetate and sodium citrate.

[0011] Preferably, the osmotic pressure of the compound contact lens care solution is 260~340 mOsm / Kg.

[0012] Preferably, the pH value of the contact lens compound maintenance solution is 6.5 to 7.8.

[0013] This invention provides a method for preparing the compound contact lens care solution described above, comprising the following steps: The components of the contact lens compound care solution are mixed to obtain the contact lens compound care solution.

[0014] This invention provides a compound contact lens care solution, comprising 1000 parts by weight, including: 0.2-14 parts of a moisturizing composition, 0.001-0.005 parts of a preservative, 6-10 parts of a buffer, 1-6 parts of an osmotic pressure regulator, 0.1-1 parts of a chelating agent, and the balance being water; the moisturizing composition consists of sodium hyaluronate, propylene glycol, and ectoine. This invention combines sodium hyaluronate, propylene glycol, and ectoine to form a moisturizing composition. Sodium hyaluronate and propylene glycol work synergistically in moisturizing, increasing the moisturizing effect; ectoine's strong hydrating properties maintain a moist environment on the ocular surface, enhancing the overall moisturizing performance of the formula. Simultaneously, ectoine is a cell protectant that can stabilize corneal epithelial cells and inhibit contact lens friction, tear osmotic pressure changes, and irritation to ocular surface cells caused by preservatives. Furthermore, sodium hyaluronate, propylene glycol, and ectoine all possess high safety and excellent biocompatibility with ocular tissues, ensuring that the contact lens compound solution also exhibits excellent safety and biocompatibility. The components of this invention's contact lens compound solution are not simply an additive combination, but rather a moisturizing composition formed by compounding sodium hyaluronate, propylene glycol, and ectoine. This reduces eye irritation from both the contact lenses and the solution components in terms of moisturizing, water retention, and cell protection, alleviating dryness and discomfort, and improving eye comfort.

[0015] The contact lens compound care solution provided by this invention allows wearers to simultaneously experience immediate lubrication, long-lasting hydration and comfort, and a deep sense of soothing and reassurance after use, achieving a comprehensive comfort experience from both physical and biological levels. It significantly reduces the potential irritation risk to sensitive eyes and is suitable for a wide range of people who need to wear contact lenses long-term or daily, including those with sensitive or dry eyes.

[0016] This invention provides a method for preparing compound contact lens care solution. It does not require high temperature, high pressure, special equipment or complex processes. The conditions are mild and easy to control. It has good reproducibility, low cost and is suitable for large-scale industrial production, and has good industrialization prospects. Detailed Implementation

[0017] In this invention, unless otherwise specified, all raw materials / components used in the preparation are commercially available products well known to those skilled in the art.

[0018] This invention provides a compound contact lens care solution, comprising, in a total mass fraction of 1000 parts: 0.2-14 parts of a moisturizing composition, 0.001-0.005 parts of a preservative, 6-10 parts of a buffer, 1-6 parts of an osmotic pressure regulator, 0.1-1 parts of a chelating agent, and the balance being water; the moisturizing composition comprises sodium hyaluronate, propylene glycol, and ectoine.

[0019] The components of the contact lens compound care solution of the present invention, based on a total mass of 1000 parts, include 0.2 to 14 parts of a moisturizing composition.

[0020] This invention combines sodium hyaluronate, propylene glycol, and ectoine to form a moisturizing composition. Sodium hyaluronate and propylene glycol work synergistically to enhance the moisturizing effect. Ectoine's strong hydrating properties maintain a moist environment on the ocular surface, enhancing the overall moisturizing performance of the formula. Simultaneously, ectoine stabilizes corneal epithelial cells, inhibiting irritation caused by contact lens friction, tear osmotic pressure changes, and preservatives. Furthermore, sodium hyaluronate, propylene glycol, and ectoine all possess high safety and excellent biocompatibility with ocular tissues, and the moisturizing composition also exhibits excellent safety and biocompatibility. This invention's moisturizing composition, through the combination of sodium hyaluronate, propylene glycol, and ectoine, reduces irritation to the eyes from contact lens and solution components in terms of moisturizing, water retention, and cell protection, alleviating dryness and discomfort, and improving eye comfort.

[0021] As one embodiment of the present invention, the components of the moisturizing composition include 0.01 to 2 parts of sodium hyaluronate by mass, and may further be 0.05 to 0.8 parts, specifically 0.05 parts, 0.1 parts, 0.3 parts, 0.5 parts and 0.8 parts.

[0022] In one embodiment of the present invention, the moisturizing composition comprises, by weight, 0.1 to 6 parts of propylene glycol, more specifically 0.5 to 5 parts, and more specifically 0.5, 2, and 5 parts.

[0023] As one embodiment of the present invention, the components of the moisturizing composition include 0.1 to 6 parts of ectoine by mass, and more specifically 0.5 to 5 parts, specifically 0.5 parts, 2 parts and 5 parts.

[0024] This invention regulates the contact angle of the compound contact lens care solution by adjusting the mass ratio of sodium hyaluronate, propylene glycol, and ectoine in the moisturizing composition, thereby regulating the moisturizing effect of the compound contact lens care solution.

[0025] The components of the contact lens compound care solution of the present invention, based on a total mass of 1000 parts, include 0.001 to 0.005 parts of preservative; as one embodiment of the present invention, the preservative may further be 0.001 to 0.003 parts, specifically 0.0012 parts; the preservative is one or more of polyhexamethylene biguanide, polyquaternium salt, and sodium chlorite.

[0026] The components of the contact lens compound maintenance solution of the present invention, based on a total mass of 1000 parts, include 6 to 10 parts of buffer; as one embodiment of the present invention, the buffer can further be 8 to 10 parts, specifically 8.9 parts; the buffer is one or more of sodium dihydrogen phosphate-disodium hydrogen phosphate, tromethamine-hydrochloric acid, and boric acid-borax.

[0027] The components of the contact lens compound maintenance solution of the present invention, based on a total mass of 1000 parts, include 1 to 6 parts of an osmotic pressure regulator; as one embodiment of the present invention, the osmotic pressure regulator may further be 2 to 5 parts, specifically 2 parts, 3 parts, 4 parts and 5 parts; the osmotic pressure regulator is sodium chloride and / or potassium chloride.

[0028] The components of the contact lens compound maintenance solution of the present invention, based on a total mass of 1000 parts, include 0.1 to 1 part of a chelating agent; as one embodiment of the present invention, the chelating agent may further be 0.3 to 0.7 parts, specifically 0.5 parts; the chelating agent is one or both of disodium ethylenediaminetetraacetate and sodium citrate.

[0029] The components of the contact lens compound care solution of this invention, based on a total mass fraction of 1000 parts, include water. The water is purified water; this invention achieves the total mass fraction of the contact lens compound care solution to 1000 parts by adding purified water.

[0030] This invention adjusts the mass fraction of osmotic pressure regulator and buffer to achieve an osmotic pressure of 260~340 mOsm / Kg and a pH value of 6.5~7.8 for the compound contact lens care solution, ensuring excellent biocompatibility, reducing eye irritation and discomfort caused by the components of the compound contact lens care solution, and improving the wearing comfort of contact lenses.

[0031] This invention provides a method for preparing the compound contact lens care solution described above, comprising the following steps: The components of the contact lens compound care solution are mixed to obtain the contact lens compound care solution.

[0032] As one embodiment of the present invention, the preferred method for mixing the components of the contact lens compound care solution includes: mixing a moisturizing composition, a buffer, an osmotic pressure regulator, a chelating agent, and 800 parts by weight of pure water, stirring for a first time until completely dissolved, then adding a preservative and stirring for a second time until completely dissolved, and finally adding the remaining pure water to a total weight of 1000 parts. The preparation of the contact lens compound care solution is carried out at room temperature. The present invention does not specifically limit the order of adding the components of the contact lens compound care solution. The first stirring speed is 300-500 rpm, specifically 400 rpm, and the time is 20-40 min, specifically 30 min. The second stirring speed is 300-500 rpm, specifically 400 rpm, and the time is 20-40 min, specifically 30 min.

[0033] This invention mixes other components to make the system completely stable, homogeneous, and clear before adding preservatives. This allows the preservatives to dissolve in a stable, homogeneous, and mild system, maximizing the preservation of their original structure and effective antibacterial concentration. This avoids incompatibilities and the risk of turbidity, improves the finished product qualification rate and storage stability, reduces eye irritation, and improves biocompatibility.

[0034] As one embodiment of the present invention, after adding the remaining pure water to a total weight of 1000 parts to obtain the prepared solution, the method further includes: filtering and sterilizing the prepared solution to obtain a compound contact lens care solution; the filtration and sterilization includes pre-filtration using a polypropylene filter cartridge and terminal filtration using a polyethersulfone sterilization-grade filter cartridge.

[0035] This invention first uses a polypropylene filter cartridge for pre-filtration to remove insoluble particles and impurities from the drug solution, preventing subsequent filter cartridges from clogging and improving filtration smoothness. Then, a polyethersulfone sterilization-grade filter cartridge is used for final filtration to trap bacteria, fungi, and other microorganisms, achieving sterilization and ensuring product sterility and safety. By using two stages of filtration in combination, both impurity removal and sterilization effects are achieved, improving product quality and process stability.

[0036] To further illustrate the present invention, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments thereof. Obviously, the described embodiments are merely some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0037] Unless otherwise specified, all materials and reagents used in the following examples are commercially available. Experimental methods not specifically described in the examples are generally performed under standard conditions or as recommended by the manufacturer. In the examples of this invention, sodium hyaluronate (HA) and ectoine are manufactured by Bloomage Biotechnology Co., Ltd., and propylene glycol is manufactured by Nanjing Welly Pharmaceutical Group Co., Ltd. All raw materials in the following examples are calculated in parts by weight.

[0038] Example 1 At room temperature, add 800 parts of pure water to a beaker. Weigh out 4 parts of sodium chloride, 8 parts of boric acid, 0.9 parts of borax, 0.5 parts of propylene glycol, 0.5 parts of ectoine, 0.8 parts of sodium hyaluronate, and 0.5 parts of disodium EDTA and add them to the beaker while stirring. After all components are added to the beaker, stir for 30 minutes to ensure complete dissolution. Add 0.0012 parts of polyhexamethylene biguanide to the beaker and stir for 30 minutes. Add pure water to bring the total weight to 1000 parts. Filter the prepared solution sequentially through a polypropylene filter and a polyethersulfone sterilization filter to obtain a compound contact lens care solution.

[0039] Example 2 It is basically the same as Example 1, except that 3 parts of sodium chloride, 2 parts of ectoine, and 0.1 parts of sodium hyaluronate are added.

[0040] Example 3 It is basically the same as Example 1, except that 2 parts of sodium chloride, 5 parts of ectoine, and 0.05 parts of sodium hyaluronate are added.

[0041] Example 4 It is basically the same as Example 1, except that 2 parts of propylene glycol are added.

[0042] Example 5 It is basically the same as Example 1, except that 3 parts of sodium chloride, 2 parts of propylene glycol, 2 parts of ectoine, and 0.1 parts of sodium hyaluronate are added.

[0043] Example 6 It is basically the same as Example 1, except that 2 parts of sodium chloride, 2 parts of propylene glycol, 5 parts of ectoine, and 0.05 parts of sodium hyaluronate are added.

[0044] Example 7 It is basically the same as Example 1, except that 4 parts of propylene glycol are added.

[0045] Example 8 It is basically the same as Example 1, except that 3 parts of sodium chloride, 4 parts of propylene glycol, 2 parts of ectoine, and 0.1 parts of sodium hyaluronate are added.

[0046] Example 9 It is basically the same as Example 1, except that 2 parts of sodium chloride, 4 parts of propylene glycol, 5 parts of ectoine, and 0.05 parts of sodium hyaluronate are added.

[0047] Comparative Example 1 It is basically the same as Example 1, except that 5 parts of sodium chloride, 2 parts of propylene glycol, and 0.1 parts of sodium hyaluronate are added, and ectoine is not added.

[0048] Comparative Example 2 It is basically the same as Example 1, except that 2 parts of propylene glycol and 2 parts of ectoine are added, and sodium hyaluronate is not added.

[0049] Comparative Example 3 It is basically the same as Example 1, except that 2 parts of ectoine and 0.1 parts of sodium hyaluronate are added, and propylene glycol is not added.

[0050] Application Example 1 The contact lens compound maintenance solutions prepared in Examples 1-9 were subjected to osmotic pressure tests, pH tests, and cytotoxicity experiments, respectively. The cytotoxicity experiments also included negative and positive control groups, which served as standard control samples for the cytotoxicity test. The negative control group consisted of phosphate buffer without calcium and magnesium ions, with a volume ratio of 15% to the culture medium; the positive control group consisted of dimethyl sulfoxide, with a volume ratio of 15% to the culture medium. In the experimental groups, the volume ratio of the contact lens compound maintenance solutions from Examples 1-9 to the culture medium was 15%. Osmotic pressure tests were performed according to the 2025 edition of the Pharmacopoeia of the People's Republic of China, Part IV, General Chapter 0632, "Determination of Osmotic Molar Concentration," using a Shanghai Medical University FM-8P freezing point osmoremeter. The test results are detailed in Table 1. pH tests were performed according to the 2025 edition of the Pharmacopoeia of the People's Republic of China, Part IV, General Chapter 0631, "Determination of pH Value," using a Mettler Toledo pH meter. The test results are detailed in Table 1. The tests were conducted according to GB / T... The cytotoxicity test was performed in accordance with the requirements of 16886.5 "Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test". The test results are detailed in Table 1.

[0051] Table 1. Physicochemical parameters and cytotoxicity test results of the compound contact lens care solutions prepared in Examples 1-9

[0052] The data in Table 1 show that the osmotic pressure of the compound contact lens care solution prepared in this invention is between 296 and 312 mOsm / kg, and the pH is between 7.25 and 7.38; meeting the requirements of GB19192-2003, the hygienic requirements for contact lens care solutions, which stipulate an osmotic pressure between 260 and 340 mOsm / kg and a pH between 6.5 and 7.8. The cell proliferation rate of the contact lens care solution prepared in this invention is greater than 80%, proving that it does not have potential cytotoxicity.

[0053] The compound contact lens care solutions prepared in Examples 4-6, the negative control group, the positive control group, and the commercially available care solutions were subjected to cytotoxicity experiments using the methods described above. The test results are detailed in Table 2.

[0054] Among them, commercially available maintenance solution A is a hyaluronic acid contact lens lubricant purchased from Weikang Company, with the following ingredients: HA (1.6mg / ml), polyaminopropyl biguanide, sodium chloride, boric acid and borax; The commercially available contact lens solution B is ANNASUI HA hyaluronic acid contact lens lubricant purchased from Zhongrun Company. Its ingredients are: sodium chloride, potassium chloride, boric acid, borax, disodium edetate, poloxamer, HA, PVP and PHMB. Commercially available contact lens solution C is Alcon contact lens lubricant (Ciba Vision / Opti-Free), with the following ingredients: sodium chloride, potassium chloride, sodium borate, HPMC (0.3%), dextran 70 (0.1%), and PQ-1 (0.001%). The commercially available contact lens solution D is Bausch & Lomb ReNu New Concept Long-Lasting Contact Lens Lubricant, purchased from Bausch & Lomb. Its ingredients are: sodium chloride, potassium chloride, boric acid, sodium borate, disodium edetate (0.1%), PVP, and sorbic acid (0.1%).

[0055] Table 2. Cytotoxicity test results of the compound contact lens care solutions prepared in Examples 4-6 and commercially available care solutions.

[0056] The data in Table 2 show that the compound contact lens care solution prepared in this invention has lower cytotoxicity, higher cell proliferation rate, and superior cell protection effect compared with the above four commercially available care solutions.

[0057] Application Example 2 The contact lens compound care solutions prepared in Examples 1-9 were tested for their antiseptic effectiveness according to the requirements of YY / T 0719.4-2009 "Ophthalmic Optical Contact Lens Care Products Part 4: Antimicrobial Preservative Efficacy Test and Determination of Disposal Date Guidelines", and the results are shown in Table 3.

[0058] Table 3. Experimental results on the preservative efficacy of the compound contact lens care solutions prepared in Examples 1-9.

[0059] The data in Table 3 show that the compound contact lens care solutions prepared in Examples 1-6 showed no growth of common harmful microorganisms after 14 and 28 days of use after opening. The preservation rates of Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa were higher than 99.9%, while the microbial concentrations of Candida albicans and Aspergillus niger were lower than the initial concentrations, meeting the requirements of YY0719.4-2009 standard. In Examples 7-9, the preservation rates of Staphylococcus aureus or Pseudomonas aeruginosa were lower than 99.9%, which did not meet the standard, indicating that the excessive addition of propylene glycol affected the product's preservation effect.

[0060] Application Example 3 The contact lens compound care solutions prepared in Examples 1-6 and Comparative Examples 1-3 were subjected to contact angle tests, and the results are shown in Table 4. A lower contact angle indicates a better moisturizing effect.

[0061] Table 4. Comparison of contact angles between the compound contact lens care solutions prepared in Examples 1-6 and Comparative Examples 1-3 and standard saline solutions.

[0062] The data in Table 4 show that all examples and comparative examples have better moisturizing effects than standard saline. The order of moisturizing effects from best to worst is as follows: Example 5 > Example 4 ≈ Example 6 > Comparative Example 1 > Comparative Example 2 > Example 3 > Example 2 > Comparative Example 3 > Example 1 > Standard Saline. This indicates that the proportions of ectoine, propylene glycol, and sodium hyaluronate affect the moisturizing performance of the contact lens compound solution. The moisturizing performance of Examples 4-6 is better than that of Examples 1-3, indicating that increasing the propylene glycol content can improve the moisturizing performance.

[0063] The contact lens compound solution prepared in Example 5 was compared with four commercially available solutions for contact angle testing. The results are shown in Table 5.

[0064] Table 5. Comparison of contact angle data between the compound contact lens solution prepared in Example 5 and four commercially available solutions.

[0065] The data in Table 5 show that the contact lens compound solution prepared in Example 5 has a lower contact angle than the four commercially available solutions mentioned above, indicating that the contact lens compound solution prepared in this invention has a better moisturizing effect.

[0066] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention. Furthermore, those skilled in the art will recognize that, based on the ideas of the present invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A compound contact lens care solution, comprising, on a total mass basis of 1000 parts, the following components: The moisturizing composition comprises 0.2-14 parts of a preservative, 0.001-0.005 parts of a buffer, 6-10 parts of an osmotic pressure regulator, 1-6 parts of a chelating agent, and the balance being water; the components of the moisturizing composition are sodium hyaluronate, propylene glycol, and ectoine.

2. The compound contact lens care solution according to claim 1, characterized in that, The moisturizing composition comprises, by weight parts: 0.01-2 parts sodium hyaluronate, 0.1-6 parts propylene glycol, and 0.1-6 parts ectoine.

3. The compound contact lens care solution according to claim 2, characterized in that, The moisturizing composition comprises, by weight parts: 0.05-0.8 parts sodium hyaluronate, 0.5-5 parts propylene glycol, and 0.5-5 parts ectoine.

4. The compound contact lens care solution according to claim 1, characterized in that, The preservative is one or more of polyhexamethylene biguanide, polyquaternium salt, and sodium chlorite.

5. The compound contact lens care solution according to claim 1, characterized in that, The buffer is one or more of sodium dihydrogen phosphate-disodium hydrogen phosphate, tromethamine-hydrochloric acid, and boric acid-borax.

6. The compound contact lens care solution according to claim 1, characterized in that, The osmotic pressure regulator is sodium chloride and / or potassium chloride.

7. The compound contact lens care solution according to claim 1, characterized in that, The chelating agent is one or both of disodium ethylenediaminetetraacetate and sodium citrate.

8. The compound contact lens care solution according to any one of claims 1 to 7, characterized in that, The osmotic pressure of the compound contact lens care solution is 260~340 mOsm / Kg.

9. The compound contact lens care solution according to any one of claims 1 to 7, characterized in that, The pH value of the compound contact lens care solution is 6.5~7.

8.

10. A method for preparing the compound contact lens care solution according to any one of claims 1 to 9, comprising the following steps: The components of the contact lens compound care solution are mixed to obtain the contact lens compound care solution.

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