Eye wash containing PDRN and EGT and preparation method thereof

Abstract

The invention discloses a PDRNamp and a method for preparing the PDRNamp. The invention discloses EGT eye wash as well as a preparation method and application thereof, and belongs to the technical field of eye care products. The eye wash is prepared from the following active components in percentage by mass: 0.001 to 0.01 percent of PDRN, 0.03 to 0.1 percent of EGT (Ergothioneine), sodium hyaluronate, sodium chloride, taurine and the like, wherein the mass percent of the PDRN is 0.001 to 0.01 percent, and the mass percent of the EGT is 0.03 to 0.1 percent. Through the synergistic effect of PDRN and EGT, the product has excellent cornea repairing capacity and a powerful anti-oxidation function at the same time, and the moisturizing and soothing effects are enhanced by compounding sodium hyaluronate and taurine. The obtained eye washing liquid is an isotonic solution with neutral pH, is mild and non-irritating, does not contain preservatives, can effectively achieve multiple nursing effects of eye cleaning, moisturizing, repairing, anti-inflammatory and anti-oxidation, and is suitable for relieving xerophthalmia, assisting cornea repair and daily anti-oxidation nursing of eyes.

Description

Technical Field

[0001] This invention relates to the field of eye wash formulation technology, and more specifically to an eye wash containing PDRN and EGT and its preparation method. Background Technology

[0002] Currently, commercially available eye wash products can be mainly categorized into cleansing, moisturizing, and soothing types based on their functions. Cleansing products often rely on surfactants or saline solution to flush out foreign objects, but lack active repair capabilities for the ocular surface. Moisturizing products typically use sodium hyaluronate and polyvinyl alcohol as main ingredients, which can relieve dryness, but have limited effects in anti-oxidation and promoting cell regeneration. Soothing products often add cooling agents such as borneol and menthol, or anti-allergenic ingredients such as dipotassium glycyrrhizate; their effects are mostly temporary, and some ingredients may irritate sensitive ocular surfaces. Furthermore, for ease of preservation, most products require the addition of preservatives (such as benzalkonium chloride), which may disrupt tear film stability and damage corneal epithelial cells with long-term use. Therefore, developing a multifunctional, gentle eye wash that combines long-lasting moisturizing, active repair, and highly effective antioxidant properties without preservatives has significant market value and clinical significance.

[0003] PDRN (polydeoxyribonucleic acid) is a bioactive substance known to promote tissue repair, reduce inflammation, and stimulate angiogenesis, and it has been used in wound healing. Ergothioneine (EGT) is a naturally occurring, potent antioxidant amino acid that effectively scavenge free radicals and protects cells from oxidative damage; it is commonly used in skincare products for anti-aging. However, there are currently no reports on combining PDRN and EGT in a specific ratio, along with other excipients (such as sodium hyaluronate and taurine), in eye wash solutions. Combining the repair and antioxidant properties of both promises to provide a more comprehensive and safe integrated care solution for the complex environment of the eye. Summary of the Invention

[0004] In view of this, the present invention provides an eye wash containing PDRN and EGT and a method for preparing the same.

[0005] To achieve the above objectives, the present invention provides the following technical solution, which includes an effective amount of PDRN and ergothioneine (EGT) as active ingredients.

[0006] Preferably, the above-mentioned eye wash containing PDRN and EGT and its preparation method further includes sodium hyaluronate, sodium chloride and taurine.

[0007] Preferably, in the above-mentioned eye wash containing PDRN and EGT and its preparation method, the eye wash composition comprises the following components by mass percentage, based on the total weight of the composition: PDRN: 0.001%–0.01%; Ergothioneine (EGT): 0.03%–0.1%; Sodium hyaluronate: 0.1%–0.5%; Sodium chloride: 0.4%–0.8%; Taurine: 0.05%–0.2%.

[0008] Preferably, in the above-mentioned eye wash containing PDRN and EGT and its preparation method, the content of PDRN is 0.005%, the content of ergothioneine (EGT) is 0.06%, the content of sodium hyaluronate is 0.2%, the content of sodium chloride is 0.5%, and the content of taurine is 0.1%.

[0009] The pH value of the eye wash composition is 6.5 to 7.5.

[0010] The eye wash composition is an isotonic solution.

[0011] The eye wash composition does not contain preservatives.

[0012] Preferably, in the above-mentioned eye wash containing PDRN and EGT and its preparation method, a method for preparing the eye wash composition as described in any of the above claims is disclosed, characterized by comprising the following steps: dissolving PDRN, ergothioneine (EGT), sodium hyaluronate, sodium chloride and taurine in water for injection, stirring evenly, adjusting the pH value of the solution to a predetermined range using a pH adjuster, and then filtering and filling.

[0013] Preferably, in the above-mentioned eye wash containing PDRN and EGT and its preparation method, the pH adjuster is hydrochloric acid and / or sodium hydroxide.

[0014] Preferably, in the above-mentioned eye wash containing PDRN and EGT and its preparation method, the use of a combination of PDRN and EGT in the preparation of an eye wash for eye care, corneal repair or eye anti-oxidation purposes.

[0015] As can be seen from the above technical solution, compared with the prior art, this invention discloses an eye wash containing PDRN and EGT and its preparation method. The eye wash provided by this invention produces a significant synergistic enhancement effect by combining PDRN and ergothioneine (EGT) in a specific ratio: on the one hand, the excellent tissue repair and anti-inflammatory effects of PDRN are combined with the powerful antioxidant capacity of EGT to synergistically protect and promote the migration and repair of corneal epithelial cells, and its effect is significantly better than the simple superposition of single ingredients; on the other hand, the compounded sodium hyaluronate and taurine further enhance the long-lasting moisturizing and soothing properties of the product. The final product is an isotonic, pH neutral and preservative-free mild system that is non-irritating to the eyes, achieving multiple functions of cleansing, moisturizing, repairing, anti-oxidation and anti-inflammation in one, comprehensively improving the safety and effectiveness of eye care. Detailed Implementation

[0016] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0017] Example 1: Preparation of PDRN&EGT Eye Wash (Preferred Formula) formula: Weigh out each ingredient according to the following formula (for preparing 250ml): PDRN: 0.0125 g (0.005%) Ergothioneine (EGT): 0.15 g (0.06%) Sodium hyaluronate (molecular weight approximately 1.0 × 10⁻⁶) 6 Da): 0.5 g (0.2%) Sodium chloride: 1.25 g (0.5%) Taurine: 0.25 g (0.1%) Hydrochloric acid (1 mol / L): Appropriate amount, used to adjust pH. Sodium hydroxide (1 mol / L): Appropriate amount, used to adjust pH. Water for injection: Add to 250 ml Preparation method: a. Dissolving sodium hyaluronate: In a sterile mixing vessel, first add about 150 ml of water for injection, and slowly add the weighed sodium hyaluronate while stirring at a low speed (about 200 rpm). Continue stirring until it is completely dissolved to form a uniform and transparent gel-like solution.

[0018] b. Add other components: While stirring, add the weighed sodium chloride, taurine, ergothioneine (EGT) and PDRN to the above solution in sequence, ensuring that each component is completely dissolved before adding the next.

[0019] c. Volume adjustment and pH adjustment: Make up the volume of the solution to 250 ml with water for injection and stir well. Monitor the pH value of the solution using a calibrated pH meter, and adjust the final pH value precisely to 7.0 ± 0.2 by adding 1 mol / L hydrochloric acid or 1 mol / L sodium hydroxide solution.

[0020] d. Filtration and Filling: The prepared solution is aseptically filtered through a 0.22 μm microporous membrane. Under aseptic conditions, the filtrate is filled into pre-sterilized 5 ml disposable blow-molded PE eye drop bottles and sealed to obtain the PDRN&EGT eye wash solution.

[0021] Product Features: The prepared eye wash solution is a colorless to slightly yellow clear solution. Its osmotic pressure was tested to be 290 ± 10 mOsm / kg, which is isotonic with human tears. Sterility and bacterial endotoxin tests both met the requirements for eye drops in the Pharmacopoeia of the People's Republic of China.

[0022] Example 2: Preparation of eye wash solutions with different content ratios This embodiment aims to illustrate other feasible formulations within the content range described in claim 3. The preparation method is the same as in Example 1, only the amount of active ingredient (by weight percentage) is changed, as shown in the table below: The products prepared in Examples 2-1 to 2-3 above all have good clarity and stability, and their pH and osmotic pressure are suitable for ocular use, proving that the formulations of the present invention are feasible within the claimed scope.

[0023] Example 3: Effect Verification Experiment To verify the beneficial effects of the eye wash of the present invention, the following preliminary in vitro and animal experiments were conducted: In vitro antioxidant activity assay (DPPH free radical scavenging assay): Using the product of Example 1 as the test group and a blank buffer solution without PDRN and EGT as the control group, the results showed that the test group had a DPPH free radical scavenging rate of over 85%, which was significantly higher than that of the control group (<5%), indicating that the eye wash solution of the present invention has extremely strong in vitro antioxidant capacity.

[0024] Corneal epithelial cell (HCEC) migration assay (scratch assay): HCEC cells treated with artificial tears were used as the model group, while those treated with the product of Example 1 were used as the experimental group. Scratch healing was observed after 24 hours of culture. The cell migration rate in the experimental group was approximately 60% higher than that in the model group, indicating that the eye wash solution of this invention can significantly promote the repair and migration of corneal epithelial cells.

[0025] Rabbit eye irritation test: According to the acute eye irritation / corrosiveness test method in the "Cosmetic Safety Technical Specifications" (2015 edition), the eye wash solution prepared in Example 1 was instilled into both eyes of New Zealand white rabbits. During the observation period (1, 24, 48, and 72 hours), no abnormal irritation reactions were observed in the conjunctiva, iris, or cornea of ​​all animals, and the Draize score was 0, indicating that the eye wash solution is non-irritating to the eyes and has high safety.

[0026] Comparative Example 1: Eye Wash with Single Active Ingredient To illustrate the synergistic effect of the combination of PDRN and EGT, eye wash solutions containing only 0.005% PDRN (without EGT) and only 0.06% EGT (without PDRN) were prepared, with other components being the same as in Example 1.

[0027] In the same DPPH radical scavenging experiment, the scavenging rate of the PDRN-only group was approximately 15%, and that of the EGT-only group was approximately 65%. The sum of the scavenging rates of the two (80%) was lower than that of the composition of Example 1 (>85%), indicating that the combination was not a simple addition, but may have a synergistic enhancement effect.

[0028] In the cell scratch assay, the cell migration promotion rates of the PDRN-only group and the EGT-only group were approximately 35% and 25%, respectively, both lower than that of the composition in Example 1 (approximately 60%), further verifying the synergistic advantage of the composition in promoting repair.

[0029] Example 4: Examples of the application of the present invention The eye wash solution prepared in Example 1 can be used for: Daily eye cleansing and moisturizing: Suitable for use after prolonged use of electronic products, in dry air-conditioned environments, or after wearing contact lenses, to relieve dryness and fatigue of the eyes.

[0030] Assisted corneal repair: Suitable for mild corneal epithelial punctate defects, post-corneal surgery, or mild contact lens-related damage.

[0031] Antioxidant eye care: Suitable for people who need to resist oxidative stress in the eyes caused by environmental factors such as ultraviolet rays and blue light.

[0032] Example 5: Brief Description of Large-Scale Production Process This invention is also applicable to industrial production: In a GMP-compliant Class D clean area, a mixing tank (e.g., 1000L) with a stirring and heating jacket is used to add materials in the order and proportion described in Example 1.

[0033] Using water for injection as a solvent, the pH adjustment process is precisely controlled by an online pH meter and an automatic dispensing system.

[0034] After being sterilized by a terminal 0.22 μm cartridge filter, the liquid medicine enters the aseptic filling line and is filled and sealed into single-dose aseptic containers under Class A laminar flow protection using blow-fill-seal (BFS) integrated technology.

[0035] The products are packaged after passing visual inspection, light inspection, osmotic pressure and pH testing.

[0036] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the description is relatively simple; relevant parts can be referred to the method section.

[0037] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An ocular wash composition characterized in that, comprising an effective amount of PDRN and ergothioneine (EGT) as active ingredients.

2. The ocular wash composition of claim 1, wherein, further comprising sodium hyaluronate, sodium chloride, and taurine.

3. The ocular wash composition of claim 2, wherein, comprising the following components in mass percentage based on the total weight of the eye lotion composition: PDRN: 0.001%-0.01%; ergothioneine (EGT): 0.03%-0.1%; sodium hyaluronate: 0.1%-0.5%; sodium chloride: 0.4%-0.8%; taurine: 0.05%-0.2%.

4. The ocular wash composition of claim 3, wherein, the content of the PDRN is 0.005%, the content of the ergothioneine (EGT) is 0.06%, the content of the sodium hyaluronate is 0.2%, the content of the sodium chloride is 0.5%, and the content of the taurine is 0.1%.

5. The ocular wash composition according to any one of claims 1-4, wherein, the pH value of the eye lotion composition is 6.5-7.

5.

6. The ocular wash composition of any one of claims 1-4, wherein, the eye lotion composition is an isotonic solution.

7. The ocular wash composition according to any one of claims 1-4, wherein, the eye lotion composition does not contain a preservative.

8. A method of making the ocular wash solution composition of any one of claims 1-7, characterized in that, comprising the following steps: dissolving PDRN, ergothioneine (EGT), sodium hyaluronate, sodium chloride, and taurine in water for injection, stirring uniformly, adjusting the pH value of the solution to a predetermined range using a pH adjuster, and then filtering and filling.

9. The method of claim 8, wherein, the pH adjuster is hydrochloric acid and / or sodium hydroxide.

10. Use of a combination of PDRN and EGT in the preparation of an eye lotion for eye care, corneal repair, or eye antioxidant use.

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