KR101241577B1 - Method for manufacturing complete mold colored contact lens and colored contact lens using the same - Google Patents

Abstract

The present invention relates to a method for producing a fully-molded color contact lens that can be easily mass-produced by adding poloxamer macroma to a color pigment polymer in the production of a color contact lens, and a color contact lens manufactured by the same. The method for manufacturing a color contact lens according to the present invention facilitates the separation of the color contact lens produced from the mold, thereby solving the problem of breakage of the edge portion of the color contact lens, and reducing the manufacturing cost and time, thereby mass-producing the color contact lens. have.

Description

METHOD FOR MANUFACTURING COMPLETE MOLD COLORED CONTACT LENS AND COLORED CONTACT LENS USING THE SAME}

The present invention relates to a method for producing a fully-molded color contact lens that can be easily mass-produced by adding poloxamer macroma to a color pigment polymer in the production of a color contact lens, and a color contact lens manufactured by the same.

In general, contact lenses are lenses that are used directly on the cornea of the eye instead of glasses, and glasses have been used for the correction of severe myopia, hyperopia, and astigmatism, which have little vision correction effect. Also used.

Such contact lenses include hard hard lenses and soft soft lenses depending on the material, hard lenses have RGP lenses that transmit oxygen well, and soft lenses are daily worn lenses that sleep every day, and can sleep for 3 to 4 days. There are continuous wear lenses, and disposable lenses that are worn daily, and cosmetic lenses that have colored collars on soft lenses.

In addition, soft lenses have the disadvantages of poor optical correction ability, easy breakage, soft surfaces, easy penetration of bacteria, and contamination of proteins, etc., compared to hard lenses. % Is choosing soft lens, and neglecting cleaning, preservation and disinfection cause side effects to the eyes or reduce the life of the lens.

In Korean Patent No. 0477133, the corroding plate is corroded to a numerical range of an outer diameter of 10.0 to 11.5 mm, an inner diameter of 4.0 to 6.0 mm, and a depth of 5 to 10 microns (S1); Stirring by adding 15 to 25% by weight of the curing agent to 75 to 85% by weight of the coating polymer, stirring for about 20 to 30 hours until the curing agent is released (S2); Coating treatment step (S3) for applying a coating polymer to the lens outer surface portion; After the coating step of heat treatment for 4 to 8 hours at 100 ~ 130 ℃ (S4); And it is disclosed a sandwich method for contact lens color coating, characterized in that the processing through the step (S5) of polishing the coated portion for 30 seconds to 1 minute using the polishing liquid.

Conventional contact lens manufacturing methods are molded by a half-mold method, the lens liquid is put into the mold and then polymerized, and the molding is processed by lathe for each degree of mold, and then the surface and edges of the molding are polished and washed. After packaging and sterilization, it is completed as a soft lens.

However, the conventional method for manufacturing a contact lens has a problem in that it takes time and cost to manufacture the contact lens by including a process of processing the lens for each mold degree, polishing a surface and an edge, and the like.

In addition, the separation of the contact lens produced from the mold is not easy to remove the problem that the edge portion of the contact lens is broken, there is a problem that mass production is not easy.

Accordingly, the present inventors have repeatedly studied to develop a fully-molded manufacturing method that is easy to separate when manufacturing a color contact lens.

SUMMARY OF THE INVENTION An object of the present invention is to provide a method of manufacturing a full contact type color contact lens that can be easily separated during manufacture of a color contact lens, and a color contact lens manufactured thereby.

In order to achieve the above object, the present invention comprises the steps of preparing a color pigment polymer comprising poloxamer macroma; Coating the color pigment polymer on an inner surface of a female mold having a cavity having a shape corresponding to that of a contact lens; Preparing a lens polymer for forming the color contact lens; Injecting a lens polymer into the inner mold of the female mold and assembling a male mold to perform a thermal polymerization reaction; And separating and washing the color contact lens from the female mold after performing the polymerization reaction, thereby providing a method of manufacturing a fully molded color contact lens.

In one embodiment of the invention, the color pigment polymer comprises 10 to 30% by weight of the color pigment, 85 to 90% by weight of the polymer, 0.1 to 10% by weight of poloxamer macroma and 0.5 to 1% by weight of the initiator.

2-hydroxyethyl methacrylate, cyclohexane, a mixture thereof, and the like may be used as the polymer.

In the present invention, the female mold is made of polypropylene (PP), and the male mold is made of polybutylene terephthalate (PBT).

The female mold is prepared in advance by reflecting the degree of color contact lens.

In one embodiment of the present invention, the lens polymer is 0.1 to 10% by weight of poloxamer macroma, 75 to 85% by weight of 2-hydroxyethyl methacrylate, 5 to 10% by weight of N-vinyl pyrrolidone, hydride 5-10% by weight of oxypropyl methacrylate and 0.5-1% by weight of initiator.

Injecting the lens polymer into the inner mold of the female mold and assembling the male mold to perform a thermal polymerization reaction is preferably performed at 110 to 130 ° C. for 30 to 60 minutes.

In the present invention, the separation washing step separates the color contact lens by separating the female mold and the male mold so that the color contact lens is attached to the male mold to hydrate the male mold while maintaining the non-contact.

The present invention also provides a color contact lens manufactured according to the method described above.

The present invention facilitates the separation of the color contact lens produced from the mold by providing a color contact lens manufacturing method and the color contact lens manufactured thereby to solve the problem that the edge portion of the color contact lens is broken and to reduce the manufacturing cost and time It is possible to reduce the mass production of color contact lenses.

1 is a flow chart schematically showing a method for manufacturing a fully molded color contact lens according to the present invention.
2 and 3 are cross-sectional views of a mold for explaining a method for manufacturing a fully molded color contact lens according to the present invention.

Hereinafter, a method of manufacturing a fully molded color contact lens according to the present invention will be described in detail with reference to the accompanying drawings.

1 is a flowchart illustrating a method of manufacturing a fully molded contact lens according to the present invention.

As shown in FIG. 1, a method of manufacturing a fully molded color contact lens according to the present invention includes preparing a color pigment polymer including poloxamer macroma; Coating the color pigment polymer on an inner surface of a female mold having a cavity having a shape corresponding to that of a contact lens; Preparing a lens polymer for forming the color contact lens; Injecting a lens polymer into the inner mold of the female mold and assembling a male mold to perform a thermal polymerization reaction; And separating and washing the color contact lens from the female mold after performing the polymerization reaction.

First, a color pigment polymer comprising poloxamer macroma is prepared.

In the present invention, the color pigment polymer includes 10 to 30% by weight of the color pigment, 85 to 90% by weight of the polymer, 0.1 to 10% by weight of the poloxamer macroma and 0.5 to 1% by weight of the initiator.

Next, the color pigment polymer is coated on the inner surface of the female mold having a cavity having a shape corresponding to that of the contact lens.

As shown in FIG. 2, a female mold 21 and a male mold having a cavity 23 (shown in FIG. 3) having a shape corresponding to that of the color contact lens is shown. ) Is coated with a color pigment polymer including a poloxamer macromer on the inner molding portion 21a formed as a groove in the female mold 21.

Here, the female mold 21 is made of polypropylene (PP) material used to make the lens water, and the male mold 22 is made of PBT (Poly Butylene Terephthalate) material used to make the inner cover of the contact lens. Can be lost. In addition, the female mold 21 may be manufactured in advance by reflecting the tap water of the contact lens, and thus, it is not necessary to perform lathe processing such that the contact lens has tap water.

Meanwhile, although the female mold 21 and the male mold 22 have shown an example for forming a single contact lens in this embodiment, the female mold 21 and the male mold 22 are arranged in a plurality of cavities. Alternatively, by forming a plurality of two-dimensionally arranged, it is possible to manufacture a large amount of contact lenses by injecting a lens polymer into each of the molding portion 21a formed in a large number in the female mold 21.

Next, a lens polymer for forming the color contact lens is prepared.

In the present invention, the lens polymer is 0.1 to 10% by weight of poloxamer macroma, 75 to 85% by weight of 2-hydroxyethyl methacrylate, 5 to 10% by weight of N-vinyl pyrrolidone, and 5 to hydroxy propyl methacrylate. 10 weight percent and 0.5-1 weight percent of initiator.

For example, poloxamer macroma dissolves poloxamer 407 in benzene and adds trimethylamine and acryloyl chloride to the mixture at 77-83 ° C. for 3 hours 50 minutes to 4 hours 10 minutes. For example, it may be prepared by reacting at 80 ° C. for 4 hours, filtering the resultant of the reaction with a filter, and then dropping it in an n-hexane solution to precipitate macroma. Such poloxamer macroma can be dried at 40 ° C. for 24 hours under reduced pressure. In addition, the polymerization mixture (Polymerisation mixture) can keep the reagent mix below 24 ℃ at a low 3 hours.

In the present invention, as an initiator, 2-2'-Azobisisobutyronitrile may be used, but is not necessarily limited thereto.

Next, the lens polymer prepared as described above is injected into the inner molding part of the female mold, and the male mold is assembled to perform a thermal polymerization reaction.

As shown in FIG. 3, according to the polymerization step, the mail mold 22 is assembled to the female mold 21 to cure the polymerization at a predetermined temperature using a dry oven as a curing process. Let's go. Here, when assembling the mail mold 22 to the female mold 21, it should be closed at a time slowly, and thus air should escape from the molding part 21a, and the closed part of the mail mold 22 is slightly raised.

Injecting the lens polymer into the inner mold of the female mold and assembling the male mold to perform a thermal polymerization reaction may be performed at 110 to 130 ° C. for 30 to 60 minutes.

Finally, after performing the polymerization reaction, the color contact lens is separated from the female mold and washed.

In the present invention, the separation washing step separates the color contact lens 10 (shown in FIG. 3) from the female mold 21 after the polymerization reaction is completed. At this time, the female mold 21 and the female mold 22 form a cavity 23 having a shape corresponding to that of the color contact lens 10 so that the contact lens 10 can be manufactured by a complete mold. Therefore, it is not necessary to grind the surface and the edge portion of the contact lens 10 separately.

In addition, in the present invention, the separation washing step allows the contact lens 10 to be attached to the mail mold 22 when the female mold 21 and the mail mold 22 are separated, so that the mail is kept in contact with the worker's hand. The contact lens 10 can be separated by hydration of the mold 22. Here, for example, the contact lens 10 attached to the mail mold 22 is mixed with distilled water: sodium bicarbonate 1,000 ml: 1.0-2.0 g, for example, distilled water: sodium bicarbonate 1,000 ml: 1.5 g mixed The contact lens 10 may be naturally separated from the male mold 22 by being immersed in the mixture.

The color contact lens 10 may be cleaned by heating the bath using a double boiler and then polished with a cleaner using an ultrasonic. At this time, the color contact lens 10 is to be washed for about 20 minutes at about 121 ℃, if stuck to the water bath during the hot water, the marks remain because the defect is left to be heated separately.

In addition, the separate washing step may include an inspection process, to determine whether the defect as a product by a comprehensive inspection.

After the separation and washing step, the color contact lens 10 must be managed by tap water, and the color contact lens 10 is packaged in glass vials and sterilized, and thus, the color contact lens 10 is disposed on the color contact lens 10. The production is finished.

In addition, the manufacturing method of the fully molded color contact lens according to the present invention is not only applicable to tints and colors, but also to produce the color contact lens 10 by the full molding method, in which case of the color contact lens 10 Although it may be difficult to separate, the color contact lens 10 is slippery by using poloxamer macroma to facilitate separation.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the present invention. Such variations and modifications are intended to be within the scope of the appended claims.

Example  1: complete In the mold method  by color  Manufacturing of Contact Lenses

10% by weight of color pigments (Clariant, CIpigment violet 23), 39% by weight of 2-hydroxy ethyl methacrylate, 50% by weight of cyclonucleic acid, 0.7% by weight of fluoroxamer macroma and 2-2'azobisisobutylonitrile The color pigment polymer prepared by mixing 0.3% by weight and reacting in a water bath was coated on the inner surface with a padding machine of the female mold. Then 0.7% by weight of poloxamer macroma, 79% by weight of 2-hydroxy ethyl methacrylate, 10% by weight of N-vinyl pyrrolidone, 10% by weight of hydroxy propyl methacrylate and 2-2'azobisisobutyl 0.3 wt% of nitrile was mixed and stirred to prepare a lens polymer.

The prepared lens polymer was injected into the inner mold of the female mold, and the male mold was assembled. Then, a thermal polymerization reaction was performed at 120 ° C. for 60 minutes in a hot air dryer. Thereafter, the resulting color contact lens was separated from the female mold by a mold separator, washed by heating in a bath using a water bath, and polished with a cleaner using an ultrasonic to prepare a color contact lens of the present invention.

Test Example : color  Cytotoxicity Test of Contact Lenses

In vitro cytotoxicity testing is generally used as an initial means of assessment related to biocompatibility of various medical devices or test substances because of the relatively easy access to the test. This test was performed to evaluate the effect of the eluate of the test substance on the cell proliferation rate using a mouse fibroblast (NCTC clone 929 (L-929)).

According to the Food and Drug Administration Notification No. 2010-36, Medical Device Standard, Hard Contact Lenses / Soft Contact Lenses, 2 x MEM medium after eluting and filtering with saline solution to apply solid test substance to cells. The sample solution was prepared by mixing with. The effect of the eluate of the test substance on the proliferation of the cells by administering and culturing the passaged mouse fibroblast suspension to the prepared test solution was measured by protein quantification. Physiological saline was used as the eluent in consideration of the harsh conditions in the test substance dissolution and the situation in which the test substance was applied to the human body. This test was conducted in accordance with KTR-MED-304 of Korea Testing & Research Institute.

  1) Materials and Methods

   1.1) materials

    1) Test substance: Disposable color contact lens

    2) Elution solvent: Sterile physiological saline solution (0.9% NaCl)

      3) 2x MEM medium: Prepared with powdered MEM (gibco) (20% serum added)

    1.2) Test substance preparation

     It was eluted at 70 ° C. for 24 hours at a rate of 20 ml of physiological saline per 4 g of the test substance and filtered through a 0.22 μm syringe filter for aseptic operation. After mixing the same amount with 2 times EM medium with serum was used as the test solution. In the preparation of the sample solution, each color was prepared by mixing the same amount. In the case of the control group and the 72 hour control group, the test solution was prepared in the same manner as the test material except for the test material, and the test solutions were used for the test within 24 hours after the preparation.

     1.3) Test system

       1) Cell Name

          NCTC clone 929 (L-929)

       2) Source

          Name: ATCC

       3) Reason for choosing the municipality

        These cells are known to be highly susceptible to chemicals in cytotoxicity testing and are selected because of the abundance of data relevant to cytotoxicity testing.

       4) Culture conditions

         Culture medium: Minimum essential medium containing 10% Horse serum (pH7.4)

          Condition: Passed every 3-4 days incubated at 5% CO₂, 37 ℃.

      1.4) Test Method

       1) Rat fibroblasts (L-929) were trypsinized after monolayer culture with MEM culture medium to make cell suspensions so that the cell concentration was 10 per ml.

       2) A mixture of the same amount of the extract and the 2-fold concentration of MEM culture was used as the extract treatment culture medium, and a mixture of the same amount of the solvent and the 2-fold concentration of the MEM culture solution was used as the control culture solution.

       3) Inject 0.2 ml (2 x 10 cells) of cell suspension into 15 test tubes, and 5 ml (treatment group) of 2 ml of extract treatment culture solution was added to the other 10 (control at the start of the reaction and control for 72 hours). In the test tube of 2 ml of the control culture solution was added. Five of the test tubes containing the control cultures were immediately centrifuged to resuspend the cells from which the cultures were removed with pH 7.0 phosphate buffered saline. The suspension was centrifuged twice again to wash the cells, and then stored at 4 ° C to serve as a control at the start of the reaction. Ten test tubes of the treatment group and the 72 hour control group were immediately incubated at 37 ° C. for 72 hours using a 5% carbon dioxide gas incubator. After incubation, the monolayers were washed three times with pH 7.0 phosphate buffered saline, and treated as a control group and a 72-hour control group.

        4) The total protein content was quantitated by colorimetric method after destroying cells with test tubes of control and treatment groups. (Lowry method), the absorbance of the test tubes of each group was measured at wavelength 650nm and the average absorbance of each group was obtained. Inhibition rate was calculated.

      1.5) Judgment of growth inhibition rate

        The cell proliferation inhibition rate is calculated by the following Equation 1 according to the criteria of Hard Contact Lenses / Soft Contact Lenses of 2010-36 Medical Device Standard Notice

         [Equation 1]

According to the Korea Food and Drug Administration Notification 2010-36, Medical Device Standard (Hard Contact Lenses / Soft Contact Lenses), the cell proliferation inhibition rate of the test substance should be less than 29%.

2) results

The calculated values of the measured absorbance and inhibition of growth of the control group at the start of the reaction, the 72 hour control group and the 72 hour test substance treatment group are shown in Table 1 below. As a result of calculating the cell proliferation inhibition rate according to the given formula, the inhibition rate was 0%. Compared to the control group at the start of the reaction, the 72-hour control group and the 72-hour test substance treatment group showed a significant increase in absorbance values.

[Table 1]

* Result according to Equation 1

                (0.2018-0.0702)

            1 ------------------- x 100 = -0.15%

                (0.2016-0.0702)

3) Discussion and conclusion

In the test conditions, the group treated with the test substance and the eluate of the color contact lens for 72 hours showed a growth inhibition rate of 0% when compared to the control group for 72 hours. Therefore, the eluate of the test substance met the medical device test criteria that the cell proliferation inhibition rate should be less than 29%.

In addition, the absorbance values of the 72-hour control group and the 72-hour test substance treatment group showed a significant increase compared to the absorbance values of the reaction initiation group, indicating that rat fibroblasts were normally grown in the presence of the control solution and the test substance eluate. The validity of this test result is proved.

10: contact lens
21: female mold
22: mail mold

Claims (13)

Preparing a color pigment polymer comprising poloxamer macroma;
Coating the color pigment polymer on an inner surface of a female mold having a cavity having a shape corresponding to that of a contact lens;
Preparing a lens polymer for forming the color contact lens;
Injecting a lens polymer into the inner mold of the female mold and assembling a male mold to perform a thermal polymerization reaction; And
Separating and cleaning the color contact lens from the female mold after performing the polymerization reaction;
Including,
The color pigment polymer comprises 10% by weight of color pigment, 39% by weight of 2-hydroxy ethyl methacrylate, 50% by weight of cyclonucleic acid, 0.7% by weight of poloxamer macroma and 0.3% by weight of initiator. Color contact lens manufacturing method.
delete delete The method of claim 1,
The initiator is a 2-2 'azobisisobutylonitrile, characterized in that the fully molded color contact lens manufacturing method.
The method of claim 1,
The female mold is made of a polypropylene (PP) material, the male mold is made of a polybutylene terephthalate (PBT) material, characterized in that the fully molded color contact lens manufacturing method.
The method of claim 5, wherein
The female mold is a method of manufacturing a fully molded color contact lens, characterized in that pre-fabricated by reflecting the degree of color contact lens.
The method of claim 1,
The poloxamer macroma dissolves poloxamer 407 in benzene, and reacts the mixed solution to which trimethylamine and acryloyl chloride are added at 77 to 83 ° C. for 3 hours 50 minutes to 4 hours 10 minutes, and the result of the reaction. After filtering with a filter, dropping it in the n-hexane solution to precipitate the macroma, characterized in that the method for producing a fully molded color contact lens.
The method of claim 1,
The lens polymer is 0.1 to 10% by weight of poloxamer macroma, 75 to 85% by weight of 2-hydroxy ethyl methacrylate, 5 to 10% by weight of N-vinyl pyrrolidone, 5 to 10% by weight of hydroxy propyl methacrylate. Method for producing a fully molded color contact lens, characterized in that it comprises% and 0.5 to 1% by weight of the initiator.
The method of claim 1,
Injecting the lens polymer into the inner mold of the female mold and assembling the male mold to perform the thermal polymerization reaction, the complete mold collar, characterized in that carried out for 30 to 60 minutes at 110 ~ 130 ℃ Contact lens manufacturing method.
The method of claim 1,
The separation and washing step may include separating the color contact lens by separating the female mold and the male mold so that the colored contact lens is attached to the male mold to hydrate the male mold while maintaining the non-contact. Color contact lens manufacturing method.
11. The method of claim 10,
In the separating and washing step, the color contact lens attached to the mail mold is immersed in a mixture of distilled water: sodium bicarbonate 1,000 ml: 1.0 to 2.0 g, so that the color contact lens is separated from the mail mold. Method for manufacturing fully molded color contact lenses.
The method of claim 11,
The separating and washing step includes heating the color contact lens with a bath and washing, and then polishing the cleaner using ultrasonic.
The color contact lens manufactured according to the manufacturing method of the fully-molded color contact lens as described in any one of Claims 1-12.

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