KR20230060752A - A resin composition for an in vitro diagnostic kit and a molded article prepared therefrom - Google Patents

Abstract

The present invention provides a resin composition for an in vitro diagnostic kit including a copolymer polymerized by including: methyl (meth)acrylate; and hydrophilic acrylic monomers such as C_1-C_6alkyl hydroxyalkyl (meth)acrylate, (meth)acrylic acid or a mixture thereof, and a molded article manufactured therefrom. The hydrophilicity of the molded article manufactured from the resin composition for an in vitro diagnostic kit is excellent, provides permanent hydrophilicity, and prevents oil pollution by including a hydrophilic acrylic.

Description

A resin composition for an in vitro diagnostic kit and a molded article prepared therefrom {A resin composition for an in vitro diagnostic kit and a molded article prepared therefrom}

The present invention relates to a resin composition for an in vitro diagnostic kit comprising a copolymer prepared by including methyl (meth)acrylate and a hydrophilic acrylic monomer and a molded article manufactured therefrom.

Due to recent epidemics such as COVID-19, demand for disposable in vitro diagnostic kits has increased internationally. In addition, there is a high risk that infectious diseases will spread globally in the future. Therefore, it is more necessary to develop technology for in vitro diagnostic kits, especially materials for disposable in vitro diagnostic kits.

The latest disposable in vitro diagnostic kit capable of performing the fastest and most accurate diagnosis is a disposable in vitro diagnostic kit using immunofluorescence. A simple diagnosis method of the immunofluorescence method is to prepare a sample by mixing and stirring a measurement object and a reagent, put the prepared sample into a cartridge, and irradiate plasma to detect a specific compound.

Disposable in vitro diagnostic kits using immunofluorescence have the advantages of high accuracy and very fast diagnosis time. However, the disadvantage of the disposable diagnostic kit of the immunofluorescence method is that the accuracy decreases over time, and thus the storage period is very short. This is caused by a technical problem of the organic material included in the disposable in vitro diagnostic kit, and it is related to the hydrophilic nature of the organic material.

Transparent polymer resins such as polycarbonylate, polymethyl methacrylate, glycol-modified polyethylene terephthalate, amorphous polyterephthalate, polystyrene, or silica-based polymers are used as organic materials included in conventional disposable in vitro diagnostic kits. Among them, polymethyl methacrylate is the most commonly used polymer for disposable in vitro diagnostic kits because of its excellent transparency and eco-friendliness.

As described above, the organic material included in the disposable in vitro diagnostic kit must have high hydrophilicity. In order to maintain the hydrophilicity of polymethylmethacrylate included in conventional disposable in vitro diagnostic kits, plasma was irradiated to impart hydrophilicity to polymethylmethacrylate resin. However, the hydrophilicity of polymethyl methacrylate irradiated with plasma decreases over time.

Therefore, it is necessary to develop a new organic material with permanent hydrophilicity, and a disposable in vitro diagnostic kit containing the new organic material is expected to increase lifespan, increase diagnostic accuracy, and shorten diagnosis time.

Republic of Korea Patent Publication 10-2012-0055061

In order to solve the conventional problems, an object of the present invention is to provide a resin composition for an in vitro diagnostic kit comprising a copolymer prepared by including methyl (meth)acrylate and a hydrophilic acrylic monomer.

Another object of the present invention is to provide a molded article manufactured from the disposable in vitro diagnostic kit.

Another object of the present invention is to provide the molded article as a material for an in vitro diagnostic kit.

Another object of the present invention is to provide a molded product having a water contact angle of 60° or less.

Another object of the present invention is to provide a new copolymer permanently hydrophilic.

The present invention is (A) 70 to 90% by weight of methyl (meth)acrylate and (B) 10 to 30% by weight of C ₁ -C ₆ alkyl hydroxyalkyl (meth) acrylate, (meth) acrylic acid or these Provided is a resin composition for an in vitro diagnostic kit comprising a copolymer prepared by including a hydrophilic acrylic monomer that is a mixture of

According to one aspect of the present invention, the copolymer may be copolymerized by further including 0.1 to 10 parts by weight of polyalkylene glycol (meth)acrylate based on 100 parts by weight of methyl (meth)acrylate.

In the polyalkylene glycol (meth)acrylate according to one aspect of the present invention, repeating alkylene groups may be C ₁ to C ₅ .

According to one aspect of the present invention, polyalkylene glycol (meth)acrylate may have a number average molecular weight of 300 to 3,000.

The copolymer according to one aspect of the present invention may have an average molecular weight of 10,000 to 100,000 g/mol.

According to one aspect of the present invention, the resin composition for an in vitro diagnostic kit may include one or two or more selected from a UV stabilizer, an antistatic agent, a plasticizer, an antioxidant, a heat stabilizer, a lubricant, and a filler.

The present invention provides a molded article manufactured from a resin composition for an in vitro diagnostic kit according to various aspects of the present invention.

According to one aspect of the present invention, the molded article can be used as a material for a disposable in vitro diagnostic kit.

According to one aspect of the present invention, the molded article may have a water contact angle of 60° or less.

The resin composition for an in vitro diagnostic kit of the present invention includes a copolymer prepared by including methyl (meth)acrylate and a hydrophilic acrylic monomer, and thus has hydrophilicity and transparency.

In addition, a molded article manufactured from the resin composition for an in vitro diagnostic kit implements permanent hydrophilicity, and an in vitro diagnostic kit using the sexually-compatible article can achieve high diagnosis accuracy and shorten diagnosis time.

The present invention will be described in more detail through the following specific examples or examples. However, the following specific examples or examples are only one reference for explaining the present invention in detail, but the present invention is not limited thereto, and may be implemented in various forms.

In the present specification, “in vitro diagnostic kit” is a term including a disposable diagnostic kit on a substrate, an in vitro diagnostic cartridge, and a simple diagnostic kit.

Also, in the present specification, “(meth)” means that it can be omitted, and specifically, methyl (meth)acrylate represents methyl methacrylate, methyl acrylate, or a mixture thereof.

Also, unless defined otherwise, all technical and scientific terms have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms used in the description in the present invention are merely to effectively describe specific embodiments and are not intended to limit the present invention.

Also, the singular forms used in the specification and appended claims may be intended to include the plural forms as well, unless the context dictates otherwise.

In addition, when a certain component is said to "include", this means that it may further include other components without excluding other components unless otherwise stated.

Hereinafter, the resin composition for an in vitro diagnostic kit of the present invention and a molded product manufactured therefrom will be described.

The present invention (A) 70 to 90% by weight of methyl (meth) acrylate; and (B) 10 to 30% by weight of a C ₁ -C ₆ alkyl hydroxyalkyl (meth)acrylate, (meth)acrylic acid, or a hydrophilic acrylic monomer that is a mixture thereof; A resin composition for diagnostic kits is provided.

Specifically, the methyl (meth)acrylate may include only methyl methacrylate, or may be a mixture of methyl methacrylate and methyl acrylate, and more specifically, the methyl acrylate is added to 100 parts by weight of the copolymer. About 0.1 to 5 parts by weight may be included.

Copolymers polymerized with the above methyl acrylate content have the advantages of polymethyl methacrylate, have high thermal stability, and a low defect rate of molded articles made of the resin composition for in vitro diagnostic kits including the above, and are resistant to ultraviolet rays and Prevent deformation from heat.

Also, specifically, the hydrophilic acrylic monomer is a C ₁ -C ₆ alkyl hydroxyalkyl (meth)acrylate or (meth)acrylic acid, and more specifically, the C ₁ -C ₆ alkyl hydroxyalkyl (meth)acrylate It may be C1-C4, but is not limited thereto in the present invention.

According to one aspect of the present invention, the copolymer may be copolymerized by further including 0.1 to 10 parts by weight of polyalkylene glycol (meth)acrylate based on 100 parts by weight of methyl (meth)acrylate, specifically It may further include 1 to 10 parts by weight, more specifically 5 to 10 parts by weight.

The copolymer containing polyalkylene glycol (meth)acrylate in the above weight range can provide a resin composition for an in vitro diagnostic kit having excellent oil contamination prevention properties and even more excellent hydrophilicity. An in vitro diagnostic kit having excellent hydrophilicity can further facilitate precise analysis as the sample spreads widely as the surface energy decreases and the contact angle decreases.

According to one aspect of the present invention, the repeating alkylene of polyalkylene glycol (meth)acrylate may be C ₁ to C ₅ , and specifically, the repeating alkylene of polyalkylene glycol (meth)acrylate is C ₁ to C ₃ .

According to one aspect of the present invention, polyalkylene glycol (meth) acrylate may have a number average molecular weight of 300 to 3,000 g / mol, specifically, the number average molecular weight of polyalkylene glycol (meth) acrylate is 400 to 3,000 g / mol 2,000 g/mol, more specifically 500 to 1500 g/mol.

The resin composition for an in vitro diagnostic kit containing polyalkylene glycol (meth)acrylate having a number average molecular weight of the above-mentioned level does not deteriorate in transparency, does not generate a defect rate due to an increase in viscosity during processing, and has a haze value does not rise significantly

The copolymer according to one aspect of the present invention may have an average molecular weight of 10,000 to 100,000 g/mol, specifically, an average molecular weight of 30,000 to 100,000 g/mol, and more specifically, 60,000 to 100,000 g/mol.

According to one aspect of the present invention, the resin composition for an in vitro diagnostic kit may include one or two or more selected from a UV stabilizer, an antistatic agent, a plasticizer, an antioxidant, a heat stabilizer, a lubricant, and a filler.

Specifically, the resin composition for an in vitro diagnostic kit may include one or two or more selected from a lubricant, a plasticizer, and a filler, and more specifically, a lubricant, a plasticizer, or a mixture thereof, but the present invention is limited thereto. It is not.

The present invention provides a molded article manufactured from a resin composition for an in vitro diagnostic kit according to various aspects of the present invention.

According to one aspect of the present invention, the molded article may be used as a material for a disposable in vitro diagnostic kit, and specifically, the material for the disposable in vitro diagnostic kit may be a capillary inside a cartridge of the disposable in vitro diagnostic kit.

According to one aspect of the present invention, the molded article may have a water contact angle of 60 ° or less, and specifically, the molded article may have a water contact angle of 50 ° or less.

As described above, a molded article having a water contact angle of 60° or less means excellent hydrophilicity and strong stress between water and the molded article. Therefore, the water on the surface of the molded article can be widely distributed, and the diagnostic accuracy of fluorescence immunodiagnosis can be increased by plasma irradiation.

Hereinafter, the present invention will be described by way of examples. That is, the present invention can be better understood by the following examples, which are for illustrative purposes of the present invention. However, the embodiments of the present invention are not intended to limit the scope of protection defined by the appended claims.

<Measurement method>

1. Measurement of water contact angle

It was measured according to the ASTM D 5946 standard. After dropping 1 uml of water with a pipette on the sheet prepared in the following Examples and Comparative Examples, the water contact angle was measured using a water contact angle meter (KRUSS, DSA100).

2. Measurement of water contact angle over time

Measured according to the ASTM D 5946 standard, the sheets prepared in the following Examples and Comparative Examples were aged for 168 hours in an environment of 20° C. and a relative humidity of 65%. Thereafter, 1 uml of water was dropped on the aged sheet with a pipette, and then the water contact angle was measured using a water contact angle meter (KRUSS, DSA100).

3. Oil contamination measurement

On the sheets prepared in the following Examples and Comparative Examples, the thumb was smeared with oily black ink to cause oil contamination. After that, oil paper was lightly placed on the contaminated part to absorb the oil, and the degree of contamination was observed with the naked eye. The degree of contamination was indicated by ◎, O, △, and X according to the degree of contamination.

Examples 1 to 6 and Comparative Examples 1 to 5: Preparation of a sheet containing a copolymer

The production method used suspension polymerization. 2000 g of distilled water, 4 g of a dispersant for suspension polymerization (solid content: 5% by weight), and 4 g of sodium sulfate as a dispersing aid were added to a 5 liter reactor and dissolved. Monomer mixture and initiator mixed with methyl methacrylate, methyl acrylate, methyl methacrylic acid, hydroxyethylene methacrylate, hydroxyethyl acrylate and polyethylene glycol methacrylate in the content ratios shown in [Table 1] below (AIBN) After adding the mixture, it was dispersed in an aqueous phase while stirring at 400 rpm to prepare a suspension. The mixture was polymerized at 80 °C for 2 hours and 30 minutes, heated to 105 °C, further polymerized for 30 minutes, and then cooled to 30 °C. The beads obtained by the polymerization reaction were washed and dehydrated repeatedly with distilled water, and then dried.

Resin pellets were prepared by kneading the resin composition obtained as described above under a nitrogen atmosphere at a temperature of 250° C. using a twin-screw extruder having a diameter of 30 and an L/D of 40.

The manufactured pellet was made into a 1 mm sheet using a two-roll mill under the condition of 250 ° C., and was measured by the above measurement method, and the results are shown in Table 2 below.

copolymer composition MMA
(weight%) MA
(weight%) MAA
(weight%) HEMA
(weight%) HEA
(weight%) PEGMA
(weight%) Example 1 65 25 10 0 0 Example 2 62 15 15 0 0 Example 3 82.5 2.5 0 15 0 Example 4 67.5 2.5 0 30 0 Example 5 85 0 0 0 15 Example 6 90 0 0 0 10 Comparative Example 1 98 2 0 0 0 Comparative Example 2 93 2 5 0 0 Comparative Example 3 65 20 10 0 0 5 Comparative Example 4 62.5 2.5 0 30 0 5 Comparative Example 5 80 0 0 0 15 5

(MMA is methyl methacrylate, MA is methyl acrylate, MAA is methacrylic acid, HEMA is hydroxyethylene methacrylate, HEA is hydroxyethylene acrylate, PEGMA is polyethylene glycol methacrylate It is rate.)

measure Water contact angle (°) Water contact angle after aging (°) oil contamination Example 1 48 47 ○ Example 2 49 50 ○ Example 3 45 46 ○ Example 4 43 44 ○ Example 5 38 37 ○ Example 6 40 40 ○ Comparative Example 1 75 80 X Comparative Example 2 71 79 △ Comparative Example 3 45 48 ○ Comparative Example 4 35 36 ◎ Comparative Example 5 41 42 ◎

The water contact angles in Table 2 are measured values representing the hydrophilic properties of Examples and Comparative Examples. It means that the hydrophilic property is excellent, so that the measured value of a water junction contact angle is small. The water contact angle values after change with time in Table 2 show the degree to which hydrophilicity is maintained in Examples and Comparative Examples, and the smaller the difference in water contact angle values, the better the hydrophilicity is maintained.

As for the oil contamination values in Table 2, ◎ indicates almost no oil contamination, ○ indicates that a small amount of oil contamination occurs, △ indicates that oil contamination is easily observed with the naked eye, and X indicates that it is not commercially available. indicates oil contamination.

When confirming the measured value of the water contact angle of Examples 1 to 6 in Table 2, it is 50 ° or less. In addition, when checking the water contact angle measurement values after the change with time in Examples 1 to 6, the difference in the water contact angle measurement values is not large. Therefore, Examples 1 to 6 are excellent in hydrophilicity, and there is no change in hydrophilicity over time.

When checking the water contact angle measurement values of Examples 1 and 2 in Table 2, the value of Example 2 having a high methacrylic acid content is small. Also in Examples 3 and 4, Example 4 having a high content of hydroxyethyl methacrylate had a small water contact angle measurement value. In the case of Comparative Example 2, 5% by weight of methylacrylic acid was copolymerized, but the water contact angle measurement value was 71, and hydrophilicity satisfactory in the present invention was not expressed.

Comparative Examples 3 to 5 are sheets containing copolymers polymerized by further adding polyethylene glycol methacrylate, and have hydrophilic properties similar to those of Examples 1 to 6. In addition, the water contact value and the water contact angle value hardly change after the change with time.

In the case of oil contamination in Table 2, Examples 1 to 6 have ○ values, and Comparative Examples 1 to 2 have X or △ values.

In the case of Comparative Examples 3 to 5, the measured value of oil contamination is ◎ or ○, which is a result of a heterogeneous effect and less oil contamination than Examples 1 to 6.

In conclusion, the molded article prepared from the polymerized copolymer containing 10 to 30% by weight of the hydrophilic acrylic monomer of the present invention has excellent hydrophilicity and exhibits permanent hydrophilicity. In addition, since oil contamination is not easy, the molded article is more hygienic when used as a material for an in vitro diagnostic kit, so the diagnostic accuracy due to impurities does not decrease.

As described above, the present invention has been described with specific details and limited examples, but this is only provided to help a more general understanding of the present invention, the present invention is not limited to the above examples, and the field to which the present invention belongs Those skilled in the art can make various modifications and variations from these descriptions.

Therefore, the spirit of the present invention should not be limited to the described embodiments, and it will be said that not only the claims to be described later, but also all modifications equivalent or equivalent to these claims belong to the scope of the present invention. .

Claims (9)

(A) 70 to 90% by weight of methyl (meth)acrylate; and (B) 10 to 30% by weight of a C ₁ -C ₆ alkyl hydroxyalkyl (meth)acrylate, (meth)acrylic acid, or a hydrophilic acrylic monomer that is a mixture thereof; A resin composition for diagnostic kits. According to claim 1,
The copolymer is copolymerized by further including 0.1 to 10 parts by weight of polyalkylene glycol (meth)acrylate based on 100 parts by weight of methyl (meth)acrylate. According to claim 2,
The polyalkylene glycol (meth) acrylate is a resin composition for an in vitro diagnostic kit in which the repeating alkylene is C ₁ to C ₅ . According to claim 2,
The polyalkylene glycol (meth)acrylate is a resin composition for an in vitro diagnostic kit having a number average molecular weight of 300 to 3,000. According to claim 1,
The copolymer is a resin composition for an in vitro diagnostic kit having an average molecular weight of 10,000 to 100,000 g/mol. According to claim 1,
The resin composition for an in vitro diagnostic kit includes one or more selected from a UV stabilizer, an antistatic agent, a plasticizer, an antioxidant, a heat stabilizer, a lubricant, and a filler. A molded article made of the resin composition for an in vitro diagnostic kit selected from claims 1 to 6. According to claim 7,
The molded article is used as a material for a disposable in vitro diagnostic kit. According to claim 7,
The molded article has a water contact angle of 60 ° or less.