JPH01104267A - Medical soft vinyl chloride resin composition and medical utensil - Google Patents

Abstract

PURPOSE:To obtain a medical utensil excellent in the preservability of erythrocytes and having high physiological safety, autoclave sterilizable heat resistance, high transparency and flexibility, by containing a vinyl chloride resin, a plasticizer and a specific ether compound. CONSTITUTION:This medical utensil is constituted of a soft vinyl chloride resin composition containing a vinyl chloride resin, a plasticizer and an ether compound wherein at least one ether bond is contained and monovalent hydrocarbon groups bonded to the ether oxygen atom of said ether bond are respectively 3-20C linear hydrocarbon groups and a MW is 1,000 or less. When this soft vinyl chloride resin composition is brought into contact with blood, the hemolysis of erythrocytes is prevented by the action of the ether compound eluted and transferred from the resin composition and a substance suppressing platelet coagulation capacity is not eluted and, therefore, this resin composition is excellent in the safety to a living body and has excellent protective action to erythrocytes.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a medical soft vinyl chloride resin composition and a medical device. To be more specific, the present invention includes:
The present invention relates to medical soft vinyl chloride resin compositions and medical devices that have extremely high safety and do not cause hemolysis when they come into contact with blood.

(Prior Art) Currently, blood storage containers or other medical devices include:
Products made of soft vinyl chloride resin are widely used because of their good moldability, flexibility, transparency, heat resistance, and low cost. By the way, soft vinyl chloride resin used for medical purposes as described above usually contains G2- as a plasticizer.
Ethylhexyl phthalate (DOP) is used.

However, since phthalate ester plasticizers generally have a high migration property, it is known that, for example, when a soft vinyl chloride resin such as the one mentioned above comes into contact with blood, di-2-pentylhexyl phthalate is eluted into the blood. (Igaku Gaku 54 221 (1984)). It has been reported that this di-2-ethylhexyl phthalate suppresses the aggregation ability of platelets (Journal of the Japanese Society of Blood Transfusion, 2).
8 (3) 282 (1981)), for example, if blood is stored using such a storage container made of soft vinyl chloride resin, di-2-ethylhexyl phthalate may enter the body along with the stored blood during blood transfusion. There is a possibility that
This was problematic in terms of its effect on platelet function.

In order to solve this problem, the use of materials that do not contain di-2-ethylhexyl phthalate has been considered; It has become clear that when blood is stored in containers, red blood cells become hemolyzed during storage. When investigating the cause of this, it was found that this is because di-2-ethylhexyl phthalate has a hemolysis inhibiting effect (Blood 6461270~ (1984) [BI
ood 6461270- [1984) ] ). In other words, when blood is stored in a conventional blood storage container made of soft vinyl chloride resin containing di-2-ethylhexyl phthalate as a plasticizer, di-2-ethylhexyl phthalate eluted into the blood is It suppresses hemolysis of red blood cells.

For these reasons, although we are concerned about the effects of di-2-ethylhexyl phthalate on living organisms, we do not incorporate di-2-ethylhexyl phthalate into medical soft vinyl chloride-based IM fat compositions constituting medical containers. Currently, soft vinyl chloride resin is used.

(Problems to be Solved by the Invention) Therefore, an object of the present invention is to provide a novel medical soft vinyl chloride resin composition and a medical device. Another object of the present invention is to provide a medical soft vinyl chloride resin composition and a medical device that have excellent preservability for red blood cells. A further object of the present invention is to provide a medical soft vinyl chloride resin composition and a medical device with high physiological safety. A further object of the present invention is to provide a medical soft vinyl chloride resin composition and a medical device that can be sterilized in an autoclave and have heat resistance, high transparency, flexibility, and processability.

(Means for Solving the Problems) The above-mentioned features include a vinyl chloride resin, a plasticizer, and a monovalent hydrocarbon group having at least one ether bond and bonded to an ether oxygen having 3 to 3 carbon atoms, respectively. This is achieved by a medical soft vinyl chloride resin composition characterized by containing an ether compound having a molecular weight of 1,000 or less and having 20 chain hydrocarbon groups.

The present invention also provides a medical soft vinyl chloride resin composition containing 10 to 45% by weight of a plasticizer and 1 to 30% by weight of the above-mentioned ether compound. The present invention provides 1 bonded to the ether oxygen of the above-mentioned ether compound.
This is a medical soft vinyl chloride resin composition in which at least one of the hydrocarbon groups has a branched structure.

The present invention also provides a medical soft vinyl chloride resin composition in which the ether compound has two or more ether bonds. The present invention further provides a medical soft vinyl chloride resin composition in which at least two of the 7', -1-valent hydrocarbon groups bonded to ether oxygen have different chain lengths. The present invention also provides that the above-mentioned ether compound has the general formula (III') CH2-0-R'; This is a medical soft vinyl chloride type (M fat composition) which is a glycerin diether represented by the general formula (III'). , Glycerin-1-butyl-3-isostearyl ether or Serine
This shows a medical soft salt 1-hibinyl resin composition which is 1,3-bis(2-ethylhexyl) ether.

The present invention also provides a medical soft vinyl chloride resin composition in which the plasticizer has low elution properties. The present invention further provides a medical soft vinyl chloride resin composition in which the plasticizer is selected from the group consisting of trialkyl trimellitates, di-normal alkyl phthalates, and tetraalkyl pyromellitates. The present invention further provides a medical soft vinyl chloride-based tS fat composition in which the plasticizer is di-normaldecyl phthalate. The present invention further provides a medical soft vinyl chloride diencephalic composition in which the plasticizer is triofthylt limellitate.

In other words, the vinyl chloride resin, the plasticizer, and the monovalent hydrocarbon group having at least one ether bond and bonded to the ether oxygen are each a chain hydrocarbon group having 3 to 20 carbon atoms. This is achieved by a medical device characterized in that it is substantially composed of a soft vinyl chloride resin composition containing an ether compound having a molecular weight of 11,000 or less.

The present invention also provides a medical device characterized in that it is substantially composed of a soft vinyl chloride resin composition containing 10 to 45% by weight of a plasticizer and 1 to 30% by weight of the above-mentioned ether compound. . The present invention also provides a medical device in which at least one of the monovalent hydrocarbon groups bonded to the needle oxygen of the ether compound has a branched structure. The present invention also provides a medical device in which the ether compound has two or more ether bonds. The present invention further provides a medical device in which at least two of the monovalent hydrocarbon groups bonded to ether oxygen have different chain lengths. The present invention also provides that the etherified metal has the general formula (III') CH20R'CHOH(III') CH2-0-R2 (wherein R1 and R2 are each a chain hydrocarbon group having 3 to 20 carbon atoms). This shows a medical device that is a glycerin diether represented by The present invention further provides a medical device in which the glycerin diether represented by the general formula (III') is glycerin-1-butyl-3-instearyl ether or glycerin-1,3-bis(2-ethylhexyl) ether. be. The present invention also provides medical devices in which the plasticizer has low elution properties. The invention further provides a medical device in which the plasticizer is selected from the group consisting of trialkyl trimellitates, di-normal alkyl phthalates and tetraalkyl pyromellitates. The invention further provides a medical device in which the plasticizer is di-normaldecyl phthalate. The present invention further provides a medical device in which the plasticizer is trioctyl trimellitate. The present invention is further characterized in that it is a blood storage container,
The present invention also provides a medical device that can withstand autoclave sterilization.

(Function) Therefore, the medical soft vinyl chloride-based (!I) resin composition of the present invention has at least one ether bond in the soft vinyl chloride-based resin composition and has a monovalent bond bonded to ether oxygen. The biggest feature is that the hydrocarbon groups are each a chain hydrocarbon group having 3 to 20 carbon atoms, and are formed by adding an ether compound with a molecular weight of 1000 or less.Surprisingly, the above ether compounds are It has the same effect of preventing red blood cell hemolysis as 2-ethylhexyl phthalate, but unlike di-2-ethylhexyl phthalate,
It was found that no effect of suppressing platelet aggregation ability was observed. Furthermore, since the above ether compounds have sufficient compatibility with vinyl chloride resins, it is possible to use other plasticizers other than di-2-ethylhexyl phthalate, especially safer plasticizers, by blending these ether compounds. Even if a plasticizer with a high but low elution property is used, it is possible to obtain a soft vinyl chloride resin composition that has good preservation properties against red blood cells when it comes into contact with blood. That is, when the soft vinyl chloride resin composition comes into contact with blood, hemolysis of red blood cells is prevented by the action of the ether compound eluted from the resin composition, while di-2-ethylhexyl phthalate Since substances that inhibit platelet aggregation ability are not eluted, it is highly safe for living organisms and has an excellent preservation effect on red blood cells. Therefore, the medical soft vinyl chloride resin composition of the present invention is suitable as a material for medical devices, and molded products made using the material have excellent safety, processability, and flexibility. Because of its flexibility, transparency, and heat resistance, it can fully demonstrate its effects when used as a medical device, and its effects are particularly remarkable when used as a medical device that comes into contact with body fluids such as blood. - Hereinafter, the present invention will be explained in more detail based on embodiments.

The vinyl chloride resin used in the medical soft vinyl chloride resin composition according to the present invention includes polyvinylidene chloride and vinyl chloride in addition to a vinyl chloride homopolymer.
There are copolymers with other copolymerizable monomers containing at least 65% by weight, most preferably at least 75% by weight, and the average degree of polymerization is 400 to 3,000%.
0, preferably 600-2,700, most preferably 8
00 to 1,700. Comonomers for vinyl chloride include vinylidene chloride, ethylene, propylene, vinyl acetate, vinyl bromide, vinyl fluoride, styrene, vinyltoluene, vinylpyridine, acrylic acid, alkyl acrylates (e.g. methyl acrylate, ethyl acrylate, isopropyl acrylate, n-butyl acrylate, 2-ethylhexyl acrylate, etc.), methacrylic acid, alkyl methacrylate (eg, methyl methacrylate, ethyl methacrylate, 2-ethylhexyl methacrylate, etc.), acrylonitrile, methacrylateril, and the like. Furthermore, a styrene-acrylonitrile copolymer or a styrene-methacrylonitrile copolymer can be blended with the vinyl chloride resin.

In addition, as the plasticizer used in the medical soft vinyl chloride resin composition of the present invention, it is desired that the plasticizer is highly safe and more preferably has low elution properties, such as di-normal octyl phthalate, di-normal nonyl phthalate, etc. , di-normal alkyl phthalates such as di-normal decyl phthalate, di-normal undecyl phthalate, dilauryl phthalate, tri-2-ethylhexyl trimellitate,
Examples include trialkyl trimellitates such as tri-normal octyl trimellitate, tetraalkyl pyromellitates such as tetra-2-ethylhexyl pyromellitate, and particularly preferred are di-normal decyl phthalate and trioctyl trimellitate. It is. In the medical soft vinyl chloride resin composition of the present invention, the amount of these plasticizers varies depending on the type of plasticizer, but is usually 10 to 45% by weight.
, preferably 15 to 35% by weight. This is because if the amount of plasticizer is less than 10 parts Rx, the resulting composition will lack flexibility, while if it exceeds 45% by weight, there is a possibility that a bleed phenomenon will occur.

Therefore, in the medical soft vinyl chloride composition of the present invention, each monovalent hydrocarbon group having at least one ether bond and bonded to ether oxygen has 3 to 3 carbon atoms.
An ether compound having a molecular weight of 1000 or less and having 20, more preferably 4 to 18 chain hydrocarbon groups is blended. This ether compound acts as a hemolysis inhibitor in the medical soft vinyl chloride resin composition of the present invention. That is, when a product made of the medical soft vinyl chloride resin composition of the present invention comes into contact with blood, the ether compound eluted from the composition exerts a protective effect on red blood cells.

In this ether compound, each monovalent hydrocarbon group that does not bond with ether oxygen is a chain hydrocarbon group having 3 to 20 carbon atoms, because it has a chain hydrocarbon group having less than 3 carbon atoms. If one of them has a chain hydrocarbon group with more than 20 carbon atoms, it will become solid and will not be compatible with the vinyl chloride resin, resulting in it not being able to be uniformly mixed into the resin composition. This is because dispersion becomes difficult. Furthermore, if the molecular weight of this ether compound is less than 1,000, if the molecular weight exceeds 1,000, it will become solid and will not be compatible with the vinyl chloride resin, making it difficult to uniformly disperse it in the resin composition. It's for a reason.

Further, in this ether compound, it is more preferable that at least one of the monovalent hydrocarbon groups bonded to the ether oxygen has a branched structure in order to improve the compatibility with the vinyl chloride resin and the effect of suppressing hemolysis. In addition, this ether compound may have two or more ether bonds, and furthermore, in the case where it has two or more ether bonds, at least two of the monovalent hydrocarbon groups that do not bond to ether oxygen It is desirable that the chain lengths are appropriately different from the viewpoint of better inhibition of hemolysis. In this ether compound, each of the monovalent hydrocarbon groups bonded to the ether oxygen may be a saturated chain hydrocarbon group or an unsaturated chain hydrocarbon group. Such an ether compound to be blended in the medical soft whistle vinyl chloride 1M resin of the present invention is, for example, -maximum (I) R1-0-R2 (I > (wherein R1 and R2 are each carbon number 3-20
It is a chain hydrocarbon group. ), -maximum (It) R1-0(-R40+R2(II) (However, in the formula, R1 and R2 are chain hydrocarbon groups having 3 to 20 carbon atoms, and R4 is a straight chain or branched hydrocarbon group having 1 to 3 carbon atoms. is a saturated hydrocarbon group, n is an integer from 1 to 5), and -maximum (III) R6-C-0-R1 R7-C-0-R3 (III) Summer R8-C-0-R2 (However, in the formula, R1 to R3 are each a chain hydrocarbon group having 3 to 20 carbon atoms or hydrogen, and R5 to R9 are each a methyl group or hydrogen, but two of R1 to R3 are
More than one cannot become hydrogen at the same time. ) are listed as typical examples, but of course the invention is not limited to these. More specifically, −
Examples of compounds represented by maximum (I) include 2-ethylhexyl isopropyl ether, di-2-ethylhexyl ether, diisopentyl ether, diisolauryl ether, diisomyristyl ether, diisobalmityl ether, diisostearyl ether, etc. Examples of compounds represented by -maximum (II) include ethylene glycol di(2-ethylhexyl) ether, ethylene glycol 2-ethylhexyl isopropyl ether, ethylene glycol isopentyl isopropyl ether, and ethylene glycol di(2-ethylhexyl) ether. isopentyl butyl ether, ethylene glycol isolauryl iso10 pyl ether, ethylene glycol isolauryl butyl ether, ethylene glycol isomyristyl isopropyl ether, ethylene glycol; isomyristyl nibbutyl ether, ethylene glycol isopalmityl isopropyl ether, ethylene glycol isopalmityl = Butyl ether, Ethylene glycol = Isostearyl = Isobutyl ether, Ethylene glycol = Isostearyl =
Ethylene glycol diethers such as butyl ether,
Diethylene glycol di(2-ethylhexyl) ether, diethylene glycol = 2-ethylhexyl = isopropyl ether, diethylene glycol = isopentyl = isopropyl ether, diethylene glycol =
Isopentyl; butyl ether, dielene glycol =
Isolauryl isopropyl ether, diethylene glycol isolauryl butyl ether, diethylene glycol isomyristyl isopropyl ether, diethylene glycol isomyristyl butyl ether, diethylene glycol isopalmityl isopropyl ether, diethylene glycol isopalmityl
Diethylene glycol diethers such as butyl ether, diethylene glycol isostearyl isopropyl ether, diethylene glycol isostearyl butyl ether, propylene glycol di(2-ethylhexyl) ether, propylene glycol 2-ethylhexyl isopropyl ether, propylene glycol isopentyl Isopropyl ether 1. Propylene glycol isopentyl butyl ether, propylene glycol isolauryl isopropyl ether, propylene glycol isolauryl butyl ether, propylene glycol isomyristyl ingropyl ether, propylene glycol isomyristyl butyl ether, propylene glycol impalmityl isopropyl ether , propylene glycol diethers such as propylene glycol isopalmityl butyl ether, propylene glycol isostearyl isopropyl ether, propylene glycol isostearyl butyl ether, and similar triethylene glycol diethers, dipropylene glycol diethers, butylene glycol There are diethers, and compounds represented by the general formula (III) include glycerin-1,3-bis(2-ethylhexyl)ether, glycerin-1-isopropyl-3
-(2-ethylhexyl)ether, glycerin-1-
Isopropyl-3-isopentyl ether, glycerin-1-butyl-3-ypentyl ether, glycerin-1-isopropyl-3-yne lauryl ether, glycerin-1-butyl-3-yne lauryl ether, glycerin-1-isopropyl- 3-Inmyristyl ether, Glycerin-1-butyl-3-inmyristyl ether, Glycerin-1-isopropyl-3-inpalmityl ether, Glycerin-1-butyl-3-isopalmityl ether, Glycerin-1-isopropyl-3 −
Glycerin diethers such as instearyl ether and glycerin-1-butyl-isostearyl ether;
Glycerin triisopropyl ether, glycerin triisobutyl ether, glycerin triisopentyl ether, 1,3-diisopropoxy-2-(2-ethylhexyloxy)propane, 1,3-bis(ethylhexyloxy)-2-impropoxy Propane, 1,3-dibutoxy-2-(2-ethylhexyloxy)propane, 1
．． Glycerin triethers such as 3-bis(2-ethylhexyloxy)-2-butoxypropane, 1,3-diisopropoxy-2-isopentyloxypropane, 1,3-diisopentyloxy-2-butoxypropane Examples include.

Among these ether compounds, the general formula (III') CH2-○-RI HOH CH2-0-R2 (wherein R1 and R2 each have 3 to 2 carbon atoms) is particularly preferred.
0 chain hydrocarbon group. ), more preferably glycerin-1-
butyl-3-instearyl ether and glycerin-1,3-bis(2-ethylhexyl) ether. Such an ether compound is blended in the medical soft arm vinyl chloride resin composition of the present invention in an amount of 1 to 30% by weight, more preferably 3 to 15% by weight. That is, if the amount of the ether compound is less than 1% by weight, the effect of suppressing hemolysis of red blood cells will not be sufficient, while if it exceeds 30% by weight, the physical properties of the soft vinyl chloride resin composition may be deteriorated. This is because there is.

Furthermore, medical vinyl chloride fit fat composition 1 of the present invention,
Z is <g・Epoxidized vegetable oils such as epoxidized soybean oil and epoxidized linseed oil as stabilizers and auxiliary plasticizers, calcium, zinc, etc. as stabilizers, and stearic acid, lauric acid, and ricinol as necessary. Metal soaps with acids, naphthenic acids, etc., lubricants, antioxidants, etc. may be blended. The amount of epoxidized vegetable oil as a stabilizer and auxiliary plasticizer is 3 to 10% by weight, more preferably 6 to 9% by weight.
, and the amount of metal soap as a stabilizer is 0.0
5-31% by weight, more preferably 0.1-1.5% by weight
It is.

The medical vinyl chloride resin composition of the present invention can be molded by any of the methods used for conventional vinyl chloride resin compositions, such as calendar molding, extrusion molding, and plastisol molding. In addition, high frequency fusion, heat fusion, etc. are possible as adhesion methods.

The medical device of the present invention comprises a vinyl chloride resin, a plasticizer, and a hydrocarbon group having at least one ether bond as described above and bonded to an ether oxygen, each of which is a chain having 3 to 20 carbon atoms. It is essentially composed of a soft vinyl chloride surface oil composition containing an ether compound with a molecular weight of 1000 or less, which is a formula hydrocarbon, and has excellent safety, processability, flexibility, heat resistance, etc. It has physical properties and is particularly effective in inhibiting hemolysis of red blood cells. Therefore, the medical devices of the present invention preferably include medical devices that come into contact with blood or body fluids, such as blood storage containers such as blood bags, catheters, blood transfusion sets, and blood circuits, but also include packaging containers for medical devices. This also includes packaging containers for drugs such as tablets.

Next, one embodiment of the medical device according to the present invention will be described using a blood bag as an example with reference to the drawings. That is, FIG. 1 shows a blood bag, and the blood collection bag 3 made of the above-mentioned soft vinyl chloride resin composition is equipped with a plurality of peel-tab-equipped discharge ports 1 and a connecting discharge port 2, and its peripheral edge 4 The blood collection bag 3 is heat-sealed by high frequency heating or other heating means, and a blood collection tube 6 made of the above-mentioned soft vinyl chloride resin composition is connected to the blood collection bag 3, which communicates with the internal space 5 of the blood collection bag 3. Further, a puncture needle 8 is inserted one inch into the needle base 7 provided at the tip of the blood collection tube 6, and a cap 9 is attached to the puncture needle 8. Further, the connecting outlet 2 of the blood collection bag 3 is provided with a connecting tube 17 connected by a connecting needle 16 at the tip, and this connecting tube 17 is provided with the outlet 10 with a peel tab via a branch pipe 15 as described above. A connecting tube 13 made of the above-mentioned soft vinyl chloride-based resin composition is connected to the inner space 12 of the first child bag 14, which is also made of a soft vinyl chloride-based resin composition and whose peripheral edge 11 is heat-sealed. Further, these connecting tubes 17 and 13 are provided with an outlet 18 with a peel tab via a branch pipe 15, and a peripheral portion 1 similarly made of the above-mentioned soft vinyl chloride resin composition is provided.
A connecting tube 22 made of the above-mentioned soft vinyl chloride resin composition communicates with the inner space 20 of the second child bag 23 which is heat-sealed.

This dual blood bag is capable of separating the components of blood collected in a closed system. That is,
First, a predetermined amount of blood is collected from a puncture needle 8 inserted into a blood donor's vein through a blood collection tube 6 into a blood collection bag 3 . After blood collection is completed, the blood collection bag 3 is centrifuged to separate the blood into an upper layer of platelet-rich plasma and a lower layer of blood cells. Next, the platelet-rich plasma in the upper layer is pushed out from the blood collection bag 3 and passed through the connecting tubes 17 and 13 to the first child bag 1.
Transfer the platelet-rich plasma to Step 4. The first child bag 14 containing the platelet-rich plasma is further centrifuged to separate the platelet concentrate in the upper layer and the platelet-poor plasma in the lower layer. It is pushed out and transferred through the connecting tubes 13 and 22 to the second child bag 23. Blood collected in this way is separated into components by centrifugation and stored in each blood bag, so even if the blood components come into contact with the blood bags and tubes for a long time, each blood bag and tube will be separated as described above. The soft vinyl chloride resin composition of the present invention, which constitutes the composition, has excellent red blood cell protection and hardening and does not inhibit the aggregation ability of platelets, thus enabling safe and effective blood transfusion.

The above explanation has been made using blood bags as an example, but the above also applies to other medical devices such as body fluid storage containers, catheters, blood transfusion sets, blood circuits, packaging containers for medical devices, packaging containers for drugs such as tablets, etc. The flexible vinyl chloride resin composition is suitably used.

The medical device according to the present invention is sterilized before use, and ethylene oxide sterilization, autoclave sterilization, etc. are used as the sterilization method, and autoclave sterilization is preferably used. In autoclave sterilization, medical devices are usually treated at about 121°C for about 60 minutes, but as mentioned above, the medical devices of the present invention have sufficient heat resistance to withstand such autoclave sterilization conditions. It is something that you have.

(Example) The present invention will now be described in more detail based on Example G.

Example 1 A soft vinyl chloride resin composition having the composition shown in Table 1 was roll-kneaded at 155° C. for 5 minutes, and then molded into a 0.4 mm thick sheet using a press molding machine. A 20 ml mini-saliva bag was produced by stacking two of the obtained sheets and high-frequency sealing a predetermined portion. Approximately 20 ml of human CPD-added concentrated red blood cell fluid (hereinafter referred to as CRC) adjusted to a hematocrit value of approximately 70% was dispensed into the bag and stored stationary at 4°C for 4 weeks. Thereafter, the plasma hemoglobin concentration was measured using the TMB method (clinical chemistry method).
23749~(1977) [C11n, Chem,
23749-(1971)]). Also CR
The concentration of the eluate in C is 0.5m CRC after standing storage.
1 was taken out, 5 ml of isopropyl alcohol and 5 ml of diethyl ether were added to it, and after stirring, it was heated at 1500×g.
After centrifugation for 0 minutes, the supernatant was evaporated and transferred, dissolved in 1 ml of acetonitrile, and then analyzed by high performance liquid chromatography for measurement. The results are shown in Table 2.

Comparative Examples 1 to 3 Mini blood bags similar to those in Example 1 were prepared using soft vinyl chloride resin compositions having the compositions shown in Table 1, and changes in plasma hemoglobin concentration and eluate concentration were examined. The results are shown in Table 2.

(Margin below) 1 Δ.

As is clear from the results shown in Table 2, when the soft vinyl chloride sebum composition according to the present invention is used (Example 1), almost nothing is eluted into the blood using DnDP as a plasticizer. Compared to (Comparative Example 2), elution was suppressed to a low level, and when DOP was used as a plasticizer (
It showed a comparatively similar value to Comparative Example 1). On the other hand, the ether compounds blended into the flexible vinyl chloride resin composition of the present invention are glycerin-1-
In contrast, when a soft vinyl chloride tM fat composition containing 3-octyl ether was used (Comparative Example 3), the degree of hemolysis increased.

Reference experiment A platelet function recovery experiment was conducted using the following procedure.

First, a solution of glycerin-1-butyl-3-isostearyl ether 200001) m dissolved in methanol (Reference Example 1), a solution of di-2-ethylhexyl phthalate 20000 pDI dissolved in methanol (Control Example 1), Di-normal decyl phthalate 200 in methanol
A solution in which 00 pl)m was dissolved (Comparative Example 2) and methanol to which nothing was added (blank) were prepared.

Each of these solutions was added to human platelet-poor plasma at 1/100
2 ml of this platelet-poor plasma was added to 1 ml of human platelet-rich plasma and further added to Tyrode's platelet-rich plasma.
ode] solution (1 μM rJEG, 4 x 10-3 units/ml, avirase, 3,5 μ/ml BSA
(containing)) and then incubated at 37°C for 90 minutes. After this, the platelets were washed and washed by Legland et al., European Journal of Biochemistry 142.
．． 465 (1984) [Legrand et.
al., Eur, J., Biochem, 142
, 465 (1984) ] ), avirase 2μ
g protein/ml added Tyrode [ryrode co/BSA solution (0,2mM Ca (12,1mM M
gCΩ2゜5mM HEPES, 3.5■/m1B
resuspended in Tyrode's solution, pH 7.35> containing sA;
50μM in the presence of 0.2■/ml fibrinogen
The maximum aggregation ability for ADP and 10 μg/ml collagen was measured using an Agelicorder (manufactured by Kyoto Daiichi Kagaku ■). The results are shown in Table 3.

As shown in Table 3, di-2-ethylhexyl phthalate T. has an inhibitory effect on recovery of platelet aggregation ability. This suggests that di-2-ethylhexyl phthalate may inhibit platelet function when it enters the body, so it is not appropriate to incorporate it into medical soft vinyl chloride diencephalic compositions. This shows that. On the other hand, glycerin-1-butyl-3-instearyl ether and di-normaldecyl phthalate have no such inhibitory effect and can be said to be safer substances. It can be seen that the vinyl chloride resin composition has little effect on platelets.

(Effects of the Invention) - As described above, the present invention provides that a vinyl chloride resin, a plasticizer, and a monovalent hydrocarbon group having at least one ether bond and bonded to an ether oxygen each have 3 carbon atoms. It is a medical soft vinyl chloride resin composition characterized by containing an ether compound with a molecular weight of 1000 or less, which is a chain hydrocarbon group of ~20. Safety G: Excellent and conventional di-2-ethyl Like soft vinyl chloride resin compositions using hexyl phthalate as a plasticizer, it has the effect of inhibiting hemolysis of red blood cells and has various physical properties such as high moldability, flexibility, transparency, and heat resistance, and has been used conventionally. It can be molded by any molding method such as calendar molding, extrusion molding, plastisol molding, etc. Also, high frequency fusion, heat fusion, etc. can be used as an adhesive method, and it can be used for medical devices, especially blood storage containers. It is ideal as a material for medical devices that come into contact with blood, such as Furthermore, in the medical soft vinyl chloride diencephalic composition of the present invention, plasticizer 1
When blending 0 to 45% by weight and 1 to 30% by weight of the above ether compound, and when at least one of the monovalent hydrocarbon groups bonded to the ether oxygen of the above ether compound has a branched structure, further the above The ether compound has two or more ether bonds,
Furthermore, when at least two of the monovalent hydrocarbon groups bonded to the ether oxygen have different chain lengths, it is more preferable that the ether compound is a glycerin diether represented by the general formula (m'), especially glycerin -1
-butyl-3-isostearyl ether or glycerin-1,3-bis(2-ethylhexyl) ether, in addition, the plasticizer is a low-leaching one, preferably trialkyl trimellite [., dinormal alkyl phthalate] and tetraalkyl pyromellitate, more preferably di-normaldecyl phthalate or trioctyl I-limellitate, which has better safety, hemolysis-inhibiting effect, and other physical properties. Become.

The present invention also provides that the vinyl chloride resin, the plasticizer, and the monovalent hydrocarbon group having at least one ether bond and bonded to ether oxygen are each a chain hydrocarbon group having 3 to 20 carbon atoms. This medical device is characterized by being substantially composed of a soft vinyl chloride resin composition containing an ether compound with a molecular weight of 1,000 or less, so it is highly safe and exhibits an effect of inhibiting hemolysis on red blood cells. In particular, even when the medical device is a device that can come into contact with blood, such as a blood storage container, it can be said to be an extremely excellent medical device since there is no risk of denaturing blood components. Furthermore, in the medical device of the present invention, the soft vinyl chloride resin composition that substantially constitutes the medical device contains 10 to 45% by weight of a plasticizer and 1 to 3% of the above ether compounds.
0 parts by weight, and at least one of the monovalent hydrocarbon groups bonded to the ether oxygen of the ether compound has a branched structure,
Furthermore, the above ether compound has two or more ether bonds, and furthermore, one bonded to ether oxygen.
When at least two of the valent hydrocarbon groups have different chain lengths, more preferably the ether compound is a glycerin diether represented by -maximum (IIr'), especially glycerin-1-butyl-3- When the plasticizer is instearyl ether or glycerin-1,3-bis(2-ethylhexyl) ether, in addition, the plasticizer is one with low elution properties, preferably trialkyl trimellitate,
A substance selected from the group consisting of di-normal alkyl phthalate and tetra-alkyl pyromellitate, more preferably di-normal decyl phthalate or trioctyl trimellitate, has safety, hemolysis inhibiting effect, heat resistance, and transparency. , making it a better medical device in other respects such as flexibility.

[Brief explanation of the drawing]

FIG. 1 is a front view showing an embodiment of the medical device of the present invention. 3...Blood collection bag, 6...Blood collection tube, 13.
17.22... Connecting tube, 14... First child bag, 23... Second child bag. Patent applicant Terumo Kao Co., Ltd.

Claims (24)

[Claims] (1) a vinyl chloride resin, a plasticizer, and at least one
1 having ether bonds and bonded to ether oxygen
1. A flexible vinyl chloride resin composition for medical use, comprising an ether compound having a molecular weight of 1000 or less, in which each of the hydrocarbon groups is a chain hydrocarbon group having 3 to 20 carbon atoms. (2) The medical soft vinyl chloride resin composition according to claim 1, which contains 10 to 45% by weight of a plasticizer and 1 to 30% by weight of the above-mentioned ether compound. (3) 1 bonded to the ether oxygen of the above ether compound
The medical soft vinyl chloride resin composition according to claim 1 or 2, wherein at least one of the monovalent hydrocarbon groups has a branched structure. (4) The medical soft vinyl chloride resin composition according to any one of claims 1 to 3, wherein the ether compound has two or more ether bonds. (5) The medical soft vinyl chloride resin composition according to claim 4, wherein at least two of the monovalent hydrocarbon groups bonded to ether oxygen have different chain lengths. (6) The above ether compound has the general formula (III')▲mathematical formula,
There are chemical formulas, tables, etc.▼ (However, in the formula, R^1 and R^2 each have 3 carbon atoms.
~20 chain hydrocarbon groups. ) The medical soft vinyl chloride resin composition according to any one of claims 1 to 5, which is a glycerin diether represented by: (7) Claim 6, wherein the glycerin diether represented by general formula (III') is glycerin-1-butyl-3-isostearyl ether or glycerin-1,3-bis(2-ethylhexyl) ether. The medical soft vinyl chloride resin composition described in . (8) The medical soft vinyl chloride resin composition according to any one of claims 1 to 7, wherein the plasticizer has low elution properties. (9) The medical treatment according to any one of claims 1 to 8, wherein the plasticizer is selected from the group consisting of trialkyl trimellitates, dinormal alkyl phthalates, and tetraalkyl pyromellitates. Soft vinyl chloride resin composition for use. (10) The medical soft vinyl chloride resin composition according to claim 9, wherein the plasticizer is di-normaldecyl phthalate. (11) The medical soft vinyl chloride resin composition according to claim 9, wherein the plasticizer is trioctyl trimellitate. (12) The vinyl chloride resin, the plasticizer, and the monovalent hydrocarbon group having at least one ether bond and bonded to ether oxygen are each a chain hydrocarbon group having 3 to 20 carbon atoms, and the molecular weight is 1000. A medical device characterized in that it is substantially composed of a soft vinyl chloride resin composition containing the following ether compound. (13) Claim 12 is characterized in that it is substantially composed of a soft vinyl chloride resin composition containing 10 to 45% by weight of a plasticizer and 1 to 30% by weight of the above-mentioned ether compound. Medical equipment as described. (14) The medical device according to claim 12 or 13, wherein at least one of the monovalent hydrocarbon groups bonded to the ether oxygen of the ether compound has a branched structure. (15) The medical device according to any one of claims 12 to 14, wherein the ether compound has two or more ether bonds. (16) The medical device according to claim 15, wherein at least two of the monovalent hydrocarbon groups bonded to ether oxygen have different chain lengths. (17) The above ether compound has the general formula (III') ▲ There are mathematical formulas, chemical formulas, tables, etc. ▼ (However, in the formula, R^1 and R^2 each have 3 carbon atoms.
~20 chain hydrocarbon groups. ) Claims 12 to 16 are glycerin diethers represented by
Medical equipment described in any of the paragraphs. (18) Claim 17, wherein the glycerin diether represented by general formula (III') is glycerin-1-butyl-3-isostearyl ether or glycerin-1,3-bis(2-ethylhexyl) ether. Medical equipment as described in . (19) The medical device according to any one of claims 12 to 18, wherein the plasticizer has low elution properties. (20) The medical treatment according to any one of claims 12 to 19, wherein the plasticizer is selected from the group consisting of trialkyl trimellitates, dinormal alkyl phthalates, and tetraalkyl pyromellitates. Tools. (21) The medical device according to claim 20, wherein the plasticizer is di-normaldecyl phthalate. (22) The medical device according to claim 20, wherein the plasticizer is trioctyl trimellitate. (23) The medical device according to any one of claims 12 to 22, which is a blood storage container. (24) The medical device according to any one of claims 12 to 23, which can withstand autoclave sterilization.