Ophthalmic formulation comprising animal aqueous humor extract, preparation method therefor, and use thereof

Abstract

An ophthalmic formulation comprising an animal aqueous humor extract, a preparation method therefor, and use thereof. The aqueous humor is similar in composition to serum, and has lower metabolites, thereby enabling protection of the starvation-induced corneal epithelium. The ophthalmic formulation comprising the animal aqueous humor extract has the effect of treating xerophthalmia.

Description

An ophthalmic preparation containing animal aqueous humor extract and its preparation method and application Technical Field

[0001] The present invention relates to the technical field of ophthalmic drugs, and in particular to an ophthalmic preparation containing an animal aqueous humor extract, and a preparation method and application thereof. Background Art

[0002] Aqueous humor is a colorless, transparent fluid produced by the non-pigmented epithelial cells of the ciliary body, filling the anterior and posterior chambers of the eyeball. Its production rate is approximately 3.5 mL / day, or 2.5 μL / min. Its composition is similar to that of plasma, including water, protein, carbohydrates, ascorbic acid, pyruvic acid, and lactic acid. Its secretion and flow play a vital role in providing nutrients and oxygen to intraocular tissues, removing metabolic waste, and maintaining intraocular pressure (eyeball shape) and refractive index. The volume of aqueous humor in the human eye is approximately 0.3 mL.

[0003] Epidemiological studies have shown that 5%-34% of the population suffers from dry eyes, which can severely impact study, work, and daily life. Numerous treatments and medications are available for treating dry eyes, including deproteinized serum eye drops, which have demonstrated some efficacy. Aqueous humor has a similar composition to serum and produces fewer metabolites. Animal studies have also shown that aqueous humor treatment can alleviate benzalkonium chloride-induced dry eye.

[0004] In summary, the invention of an eye drop containing an animal aqueous humor extract has important clinical and scientific research significance. Technical Solutions

[0005] In order to solve the technical defects of the prior art, the present invention provides an ophthalmic preparation containing animal aqueous humor extract and a preparation method and application thereof, which are suitable for clinical and scientific research applications.

[0006] The technical solution adopted by the present invention is: an ophthalmic preparation containing animal aqueous humor extract, the ophthalmic preparation comprises animal aqueous humor and auxiliary materials and additives, and the content of animal aqueous humor in the ophthalmic preparation is greater than 50%.

[0007] The animal aqueous humor includes but is not limited to the aqueous humor obtained by extracting from the eyes of rabbits, pigs, sheep, cattle and monkeys and then sterilizing them.

[0008] The ophthalmic preparation includes one of eye drops, ointments and gel preparations.

[0009] The auxiliary materials and additives include lubricants and preservatives.

[0010] The lubricant includes but is not limited to sodium hyaluronate or polyethylene glycol.

[0011] The preservative is one or more of benzalkonium chloride, benzalkonium bromide, ethyl hydroxybenzoate, chlorobutanol or boric acid.

[0012] A method for preparing eye drops containing animal aqueous humor extract comprises the following steps:

[0013] (1) Use a syringe to puncture the anterior chamber of the rabbit's eye through the limbus of the cornea and sclera, and extract 0.15-0.2 mL of aqueous humor per eye. Collect the aqueous humor from different eyes into the inner cannula of a centrifuge tube filter. The inner cannula of the centrifuge tube filter contains a 0.22 μm sterilization membrane. After centrifugation, discard the inner cannula and keep the liquid in the outer cannula for later use.

[0014] (2) Add sterile water and 0.4% w / v polyethylene glycol 400 to a centrifuge tube and fully dissolve, then shake for later use;

[0015] (3) Add the liquid obtained from the outer tube in step (1) above to the centrifuge tube in step (2), fully dissolve and shake to obtain eye drops containing 50% rabbit aqueous humor.

[0016] The invention discloses an ophthalmic preparation containing an animal aqueous humor extract for preparing a medicine for treating dry eyes. Beneficial effects

[0017] The beneficial effects of the present invention are as follows: the present invention provides an ophthalmic preparation containing an animal aqueous humor extract, a preparation method thereof, and an application thereof; the aqueous humor has similar components to serum and has lower metabolites, and can protect the corneal epithelium induced by starvation; the ophthalmic preparation containing an animal aqueous humor extract of the present invention has the effect of treating dry eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG1 is a flow chart of the technical solution of the present invention.

[0019] Figure 2 is the benzalkonium chloride dry eye model in rabbits (corneal fluorescein staining).

[0020] Figure 3 shows the corneal fluorescein staining area.

[0021] Figure 4 shows the fluorescence intensity of corneal fluorescein staining. Modes for Carrying Out the Invention

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

[0023] Example 1 Preparation of eye drops

[0024] The technical solution includes the following specific steps:

[0025] S1. Use a syringe with a 27-30 gauge needle to penetrate the anterior chamber of the rabbit's eye through the limbus and withdraw 0.15-0.2 mL of aqueous humor per eye. Collect 2 mL of aqueous humor from each eye into the inner tube of a 2 mL centrifuge filter (a centrifuge tube with an inner and outer tube containing a 0.22 μm sterilization film). Centrifuge at 2000 RPM for 5 minutes. Discard the inner tube and reserve the liquid in the outer tube.

[0026] S2. Add 2 ml of sterile water and 16 mg of polyethylene glycol 400 (0.4%, w / v) to a centrifuge tube and dissolve thoroughly. Vortex and set aside.

[0027] S3. Add the outer tube liquid in S1 to the centrifuge tube in S2, dissolve and shake thoroughly to obtain 4 ml of eye drops containing 50% rabbit aqueous humor. The eye drops can be stored at 4°C.

[0028] The animals used for aqueous humor extraction include, but are not limited to, rabbits, pigs, sheep, cattle, and monkeys; lubricants include, but are not limited to, sodium hyaluronate and polyethylene glycol; and preservatives include, but are not limited to, benzalkonium chloride, benzalkonium bromide, ethylparaben, chlorobutanol, and boric acid. The sterilization method for the aqueous humor extract is not limited to membrane filtration.

[0029] Example 2

[0030] The inventors obtained 4 ml of eye drops containing 50% rabbit aqueous humor, 0.2% polyethylene glycol and 0.1% benzalkonium chloride according to the above technical solution, and applied the eye drops to an animal model of dry eye disease.

[0031] Applying 0.1% benzalkonium chloride eye drops twice daily, morning and evening, for seven consecutive days can create a dry eye model in rabbits (control group), demonstrating positive corneal fluorescein staining. During the dry eye modeling process, concurrent use of rabbit-derived aqueous humor eye drops twice daily effectively inhibits dry eye development, demonstrating negative corneal fluorescein staining (Figure 2). Quantitative analysis of corneal fluorescein staining revealed that the sodium fluorescein staining area (Figure 3) and fluorescence intensity (Figure 4) in the aqueous humor-treated group were significantly lower than those in the control group (i.e., the dry eye model group).

[0032] Technical personnel should note: Although the present invention has been described according to the above specific implementation methods, the inventive concept of the present invention is not limited to this invention. Any modification using the inventive concept will be included in the scope of protection of this patent.

[0033] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiment. All technical solutions based on the concept of the present invention are within the scope of protection of the present invention. It should be noted that for those skilled in the art, various improvements and modifications that do not depart from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. An ophthalmic preparation containing an animal aqueous humor extract, characterized in that: The ophthalmic preparation comprises animal aqueous humor and auxiliary materials and adjuvants, and the content of animal aqueous humor in the ophthalmic preparation is greater than 50%.

2. An ophthalmic preparation containing an animal aqueous humor extract according to claim 1, characterized in that: The animal aqueous humor includes but is not limited to the aqueous humor obtained by sterilizing after being extracted from the eyes of rabbits, pigs, sheep, cattle and monkeys.

3. An ophthalmic preparation containing an animal aqueous humor extract according to claim 1, characterized in that: The ophthalmic preparation includes one of eye drops, ointments and gel preparations.

4. An ophthalmic preparation containing an animal aqueous humor extract according to claim 1, characterized in that: The auxiliary materials and additives include lubricants and preservatives.

5. An ophthalmic preparation containing an animal aqueous humor extract according to claim 4, characterized in that: The lubricant includes but is not limited to sodium hyaluronate or polyethylene glycol.

6. An ophthalmic preparation containing an animal aqueous humor extract according to claim 4, characterized in that: The preservative is one or more of benzalkonium chloride, benzalkonium bromide, ethylparaben, chlorobutanol or boric acid.

7. A method for preparing eye drops containing animal aqueous humor extract, characterized in that: The following steps are involved: (1) Puncture the anterior chamber of the rabbit's eye through the limbus of the cornea and sclera with a syringe to extract 0.15-0.2 mL of aqueous humor per eye, and collect the aqueous humor of different eyes in the inner sleeve of a centrifuge tube filter, wherein the inner sleeve of the centrifuge tube filter contains a 0.22 μm sterilization membrane. After centrifugation, discard the inner sleeve and keep the liquid in the outer sleeve for later use; (2) Add sterile water and 0.4% w / v polyethylene glycol 400 to a centrifuge tube and fully dissolve, then shake for later use; (3) Add the liquid obtained from the outer tube in step (1) into the centrifuge tube in step (2), and after sufficient dissolution and shaking, obtain eye drops containing 50% rabbit aqueous humor.

8. Use of the ophthalmic preparation containing the animal aqueous humor extract according to claim 1 in the preparation of a drug for treating dry eyes.

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