JPS61220651A - Ophthalmic injection solution - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] [Field of Industrial Application] The present invention relates to an ophthalmic injectable solution, particularly an ophthalmic injectable solution injected into the anterior chamber for anterior chamber formation in anterior segment surgery. .

[Conventional technology]

Conventionally, in intraocular lens (artificial lens) implantation surgery, glaucoma filtration surgery, corneal transplant surgery, limited trauma repair surgery, and other anterior segment surgeries, the anterior chamber (anterior chamber) formed by the iris and cornea of the eye is used. The aqueous fluid that fills the intraocular chamber leaks out, causing the anterior chamber to contract, causing the cornea to retract and approach the intraocular lens. In such a situation, not only will it be difficult to perform the surgery itself, but there is also a strong possibility that surgical instruments will come into contact with the cornea and damage the cornea, which may even cause blindness.

For this reason, in anterior segment surgery, the aim of anterior chamber formation is to maintain the anterior chamber in the same swollen state as when it is filled with aqueous fluid. Injection of sodium hyaluronate aqueous solution is practiced.

[Problem that the invention seeks to solve]

The conventionally used sodium hyaluronate aqueous solution is
Although it is useful for anterior chamber formation, sodium hyaluronate is a substance derived from biological components and is mainly manufactured by extracting and purifying chicken combs, so it is not only very expensive but also difficult to produce. There are problems such as the fact that it is very difficult to obtain.

Means for Solving Point C88] The purpose of the present invention is to provide an ophthalmic injection solution that can be used in place of an aqueous sodium hyaluronate solution. It is intended as an ophthalmic injection.

In the present invention, an aqueous solution of at least one water-soluble high molecular weight substance selected from soluble dextran, soluble collagen, polyvinyl alcohol, alkali metal salt of polyacrylate, and alkali metal salt of polymethacrylate is used as an ophthalmic injection solution.

The soluble dextran used in the present invention is a type of polysaccharide, a polymer of D-glucose, and usually contains 60% or more of α-1,6-glucosidic bonds, and is partially hydrolyzed. The average molecular weight is, for example, 7 (about 1,000 to 300,000).

Soluble collagen is also called regenerated collagen, procollagen, etc.

Polyvinyl alcohol is polyvinyl acetate with alkali,
It is obtained by saponification with acid, ammonia, etc., and as long as it is water-soluble, it may have a degree of saponification of about 60%, for example.

Examples of the alkali metal salt of polyacrylic acid or the alkali metal salt of polymethacrylate include water-soluble polymers such as sodium salt or potassium salt of polymethacrylic acid or polyacrylic acid. Further, the polymethacrylic acid or polyacrylic acid may be a copolymer of unsaturated dicarboxylic acids such as maleic acid and itaconic acid.

In the present invention, an ophthalmic injection solution is prepared by dissolving the above-mentioned water-soluble high molecular weight substance in purified water, and this solution has a viscosity of 2X10' to 2
X105cps is preferable, especially 2X10'
~2×105 cps is preferred.

If the viscosity of this solution is too high, it will be difficult to inject into the anterior chamber with a syringe, making it impractical, and if it is too low, it will have little effect on anterior chamber formation or will leak out in a short period of time. Anterior chamber formation becomes insufficient. The concentration of this solution is therefore not particularly limited as long as a preferred viscosity can be obtained. However, the solution actually needs to be highly transparent because it is required to perform the surgery while looking through the anterior chamber into which the solution is injected using a microscope.

Further, a viscosity improver such as partially saponified acrylamide may be added to the solution of the water-soluble high molecular weight substance, if necessary.

Furthermore, a polyhydric alcohol such as ethylene glycol or propylene glycol can be added to the solution of the water-soluble high-molecular weight substance at a rate of about 20 parts by weight or less per 100 parts by weight of the water-soluble high-molecular weight substance. Subsequent removal of the injectate with clean water or physiological saline can be made easier.

〔Example〕

EXAMPLES Hereinafter, the present invention will be explained in detail with reference to Examples, but the present invention is not limited to these Examples.

Example 1 120 g of completely saponified polyvinyl alcohol with an average degree of polymerization of 2400 (degree of saponification 98.5%) was dissolved in 880 g of purified water, this solution was filtered with a 10 μm membrane filter, and an ampoule with a volume of 3 ml was prepared. The ophthalmic injection solution of the present invention was obtained by dispensing the solution into a container, sealing it, and sterilizing it by heating. The viscosity of this solution was 11.0 OO cps at 20°C.

Transfer this ophthalmic injection solution from the ampoule to a syringe,
After incision of the sclerocornea in extracapsular lens extraction, 0.4 to 0.5 ml of the injection solution was injected into the anterior chamber from a syringe. Afterwards, the anterior capsule was incised, the lens nucleus was delivered, and the lens cortex was removed by suction, but the anterior chamber remained fully formed throughout the surgery.
There was only slight leakage of the injected fluid in the anterior chamber.

Then, before inserting the intraocular lens, add an additional 0.2 to 0.
After injecting an additional 3 ml, an intraocular lens wetted with the injection solution was inserted into a predetermined position. Next, the cornea was thoroughly washed with physiological saline, and the initially incised scleroderma was sutured.

For one month from the day after the surgery, the cornea, anterior chamber, pupil, and position of the intraocular lens were examined, and the fundus of the eye was observed, but no abnormal findings were found. There was also no increase in intraocular pressure.

Example 2 Soluble dextran 300 with average molecular weight 200.000
g was dissolved in 700 g of purified water, and this solution was filtered through a 10 μm membrane filter, then dispensed into 3 ml ampoules, sealed, and heat sterilized to obtain the ophthalmic injection solution of the present invention. . The viscosity of this solution is 3.800 at 20°C.
It was cps.

Transfer this ophthalmic injection solution from the ampoule to a syringe,
In extracapsular lens extraction, 0.4 to 0.5 ml of the injection solution was injected into the anterior chamber from a syringe after incision of the sclerocornea. after that,
The anterior capsule was incised, the lens nucleus was delivered, and the lens cortex was removed by suction. Throughout the surgery, the anterior chamber was sufficiently formed, and there was only slight leakage of the injected fluid within the anterior chamber.

Then, before inserting the intraocular lens, add an additional 0.2 to 0.
After injecting an additional 3 ml, an intraocular lens wetted with the injection solution was inserted into a predetermined position. Next, the cornea was thoroughly washed with physiological saline, and the initially incised scleroderma was sutured.

For one month from the day after the surgery, the cornea, anterior chamber, pupil, and position of the intraocular lens were examined, and the fundus of the eye was observed, but no abnormal findings were found. There was also no increase in intraocular pressure.

Example 3 Soluble collagen was dissolved in purified water, and this solution was dissolved in 10μ
After filtration with a membrane filter of 1.0 m, the solution was dispensed into ampoules with a volume of 3 ml, sealed, and sterilized by heat to obtain the ophthalmic injection solution of the present invention. The viscosity of this solution is 2L at 20℃
000 cps.

Transfer this ophthalmic injection solution from the ampoule to a syringe,
In extracapsular lens extraction, 0.4 to 0.5 ml of the injection solution was injected into the anterior chamber from a syringe after incision of the sclerocornea. after that,
The anterior capsule was incised, the lens nucleus was delivered, and the lens cortex was removed by suction. Throughout the surgery, the anterior chamber was sufficiently formed, and there was little leakage of injected fluid within the anterior chamber.

Then, before inserting the intraocular lens, add an additional 0.2 to 0.
After injecting an additional 3 ml, an intraocular lens wetted with the injection solution was inserted into a predetermined position. Next, the cornea was thoroughly washed with physiological saline, and the initially incised scleroderma was sutured.

For one month from the day after the surgery, the cornea, anterior chamber, pupil, and position of the intraocular lens were examined, and the fundus of the eye was observed, but no abnormal findings were found. There was also no increase in intraocular pressure.

Example 4 30 g of sodium polyacrylate having a degree of polymerization of 15.000 to 20.000 was dissolved in 970 g of purified water, and after filtering this solution with a 10 μm membrane filter, it was dispensed into 3 ml ampoules. After sealing, the container was heat sterilized to obtain an ophthalmic injection solution of the present invention. The viscosity of this solution is 20
It was 27,000 cps at ℃.

Transfer this ophthalmic injection solution from the ampoule to a syringe,
In extracapsular lens extraction, 0.4 to 0.5 ml of the injection solution was injected into the anterior chamber from a syringe after incision of the sclerocornea. after that,
The anterior capsule was incised, the lens nucleus was delivered, and the lens cortex was removed by suction. Throughout the surgery, the anterior chamber was sufficiently formed, and there was only slight leakage of the injected fluid within the anterior chamber.

Then, before inserting the intraocular lens, add an additional 0.2 to 0.
After injecting an additional 3 ml, an intraocular lens wetted with the injection solution was inserted into a predetermined position. Next, the cornea was thoroughly washed with physiological saline, and the initially incised scleroderma was sutured.

For one month from the day after the surgery, the cornea, anterior chamber, pupil, and position of the intraocular lens were examined, and the fundus of the eye was observed, but no abnormal findings were found. There was also no increase in intraocular pressure.

〔Effect of the invention〕

The ophthalmological injection solution of the present invention is as described above, and since the injection solution is an aqueous solution of a water-soluble high molecular weight substance, it is inexpensive and relatively easy to obtain. High molecular weight substances can be obtained at extremely low prices through mass production.

In addition, since the viscosity of the aqueous solution is preferably within the range of 2 x 10'' to 2 x 10' cps at a temperature of 20°C, it is easy to inject into the anterior chamber with a syringe, etc. Chamber formation is achieved and it can be used as well as in place of aqueous sodium hyaluronate solutions, making it extremely useful in anterior segment surgery.

Furthermore, the ophthalmic injection solution injected into the anterior chamber needs to be washed out after surgery, but since the solute in the injection solution of the present invention is water-soluble, it can be sufficiently washed out with clean water or physiological saline. It is.

Claims (1)

[Claims] 1) An ophthalmic injection solution comprising an aqueous solution of at least one water-soluble high molecular weight substance selected from soluble dextran, soluble collagen, polyvinyl alcohol, alkali metal salts of polyacrylates, and alkali metal salts of polymethacrylates. .