CN104371210B - 一种高透氧型血小板贮存医用pvc材料及其制备方法 - Google Patents
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- C—CHEMISTRY; METALLURGY
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- C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L27/04—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
- C08L27/06—Homopolymers or copolymers of vinyl chloride
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- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- C—CHEMISTRY; METALLURGY
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Abstract
本发明公开了一种高透氧型血小板贮存医用PVC材料及其制备方法，包括以下重量份的组分：聚氯乙烯树脂100份；增塑剂45—60份；热稳定剂5—10份；润滑剂0.1—2份；功能性助剂0.1—0.5份，所述的功能性助剂为乳酸钠。本发明配方合理，性能稳定，工艺简单，成本低。有效提高了血小板保存袋的透氧性，延长了血小板的保存寿命，对我国乃至世界医疗卫生事业的发展具有重大实际意义。
Description
技术领域
本发明涉及一种改性聚氯乙烯(PVC)材料及其制备方法，具体地说是不含邻苯二甲酸(2-乙基己酯)(DEHP)类增塑剂的高透氧型血小板贮存医用PVC材料。
背景技术
随着我国医疗卫生事业的迅速发展，一次性输液(血)器等医疗用品的需求也持续走高。据估计，我国每年使用血袋将近1500万套，其塑料基材可达数万吨。尽管目前在医用聚丙烯，聚乙烯，弹性体，聚酯和尼龙等领域的研究有所进展，但由于综合性能优越，价格相对低廉，PVC医用粒料依然是生产一次性使用输液(血)等用品的主要原料之一。迄今为止，用于保存全血和红细胞并对红血球的保存周期可与聚氯乙烯相当的理想聚烯烃材料仍没有问世，因此，PVC医用粒料仍是全血、血红细胞及血小板的最理想的包装材料之一。
随着医疗事业的发展和临床经验及数据的积累，发现目前国内用于贮存血小板的普通塑料血袋依然存在一些缺陷，其中最主要问题在于材料的透氧性的不足。研究表明，在血小板贮存过程当中，正常代谢类型为有氧代谢，消耗氧气，释放二氧化碳；而由于血袋的透气性不佳，氧气在初期将很快消耗殆尽，代谢类型也将转变为无氧代谢，此时就会造成大量的乳酸堆积。众所周知，乳酸降低pH的能力远超二氧化碳，因此血小板浓缩液的pH值也随之迅速降低，甚至可低至5以下。而从理论上讲，血小板保存的最佳pH为接近生理水平的7.2，在pH为6.5～7.0时，血小板三天内的失活率为30％～50％，而pH值一旦低至6.0以下，血小板将迅速失活。因此，pH值的迅速下降是导致血小板保存期不长的直接原因，而pH值的控制可通过提高材料的透氧性或者抑制pH值降低两个方面来实现。目前，国内血小板保存期为1～3天，不能满足临床应用的需要。
发明内容
本发明的目的是提供一种高透氧型血小板贮存医用PVC材料及其制备方法，以克服现有技术存在的缺陷。
所述的高透氧型血小板贮存医用PVC材料，包括以下重量份的组分：
优选的，所述的高透氧型血小板贮存医用PVC材料，其特征在于，包括以下重量份的组分：
所述的聚氯乙烯为悬浮法制备的超高分子量聚氯乙烯或中分子量聚氯乙烯树脂的一种或几种，其分子量在在6～18万，K值在65～90；
所述的增塑剂选取环己烷-1、2-二羧酸二异壬酯(DINCH)、乙酰柠檬酸三正丁酯(ATBC)、乙酰柠檬酸三(2-乙基己)酯(ATOC)或偏苯三酸三(2-乙基己酯)(TOTM)等中的两到三种；
优选的为：DINCH和ATBC的混合物，重量比为：DINCH∶ATBC＝1∶1.5～2.5；或者为：DINCH、ATBC和TOTM的混合物，重量比为：DINCH∶ATBC∶TOTM＝1∶1.8～2.2∶0.5～0.8；
所述的稳定剂为液体复配Ca/Zn稳定剂、环氧大豆油等中的一种或几种；
所述的润滑剂选自聚乙烯蜡、氯化聚乙烯蜡、硬脂酸或硅油的一种以上；
所述的功能性助剂为乳酸钠等物质；
所述的高透氧型血小板贮存医用PVC材料的制备方法，包括如下步骤：
(1)预混料的制备，将聚氯乙烯树脂、功能助剂、稳定剂、增塑剂以及润滑剂，在80～140℃预混，得预混料；
(2)挤出料的制备，将预混料加入双螺杆挤出机，在130～180℃进行塑化挤出造粒，制得所述高透氧性血小板贮存袋材料的粒料；
本发明采用的功能性助剂乳酸钠在预混过程均匀分散在混合料当中，制成制品时以螯合物形式存在；在血小板贮存过程当中，由于溶液介质的存在，乳酸钠将逐渐被溶出，进入血小板溶液，并在膜材上留下微孔，此微孔的存在既能有效提高气体通透性又不会造成溶液的流失。另外，进入血小板溶液的乳酸钠为强碱乳酸盐，还能起到部分缓冲液的作用，有利于进一步调节pH。
本发明的材料，可以按照通用软质PVC材料的压延或流延工艺制成血袋，产品在透氧性的测试结果远优于市场上同类产品，实例见附表。
本发明配方合理，性能稳定，工艺简单，成本低。有效提高了血小板保存袋的透氧性，延长了血小板的保存寿命，对我国乃至世界医疗卫生事业的发展具有重大实际意义。
具体实施方式
实施例1
制备方法：
(1)预混料的制备，在搅拌机中依次加入PVC树脂，功能助剂，稳定剂，增塑剂以及润滑剂，在130℃预混，得预混料；
(2)挤出料的制备。将预混料加入双螺杆挤出机，在160℃进行塑化挤出造粒，获得产品。
实施例2
制备方法：
(1)预混料的制备。在高速搅拌机中依次加入PVC树脂，功能助剂，稳定剂，增塑剂以及润滑剂，在130℃预混，得预混料。
(2)挤出料的制备。将预混料加入双螺杆挤出机，在165℃进行塑化挤出造粒，获得产品。
采用GB/T1038-2000标准进行检测，结果如下：
附表：透氧性能对比
Claims (6)
1.高透氧型血小板贮存医用PVC材料，其特征在于，包括以下重量份的组分：
所述的功能性助剂为乳酸钠；
所述的聚氯乙烯为悬浮法制备的超高分子量聚氯乙烯或中分子量聚氯乙烯树脂的一种或几种，其分子量为6～18万，K值在65～90；
所述的增塑剂选自环己烷-1、2-二羧酸二异壬酯(DINCH)、乙酰柠檬酸三正丁酯、乙酰柠檬酸三(2-乙基己)酯或偏苯三酸三(2-乙基己酯)(TOTM)中的两到三种。
2.根据权利要求1所述的高透氧型血小板贮存医用PVC材料，其特征在于，包括以下重量份的组分：
3.根据权利要求1所述的高透氧型血小板贮存医用PVC材料，其特征在于，增塑剂选自DINCH和ATBC的混合物，重量比为：DINCH∶ATBC＝1∶1.5～2.5。
4.根据权利要求1所述的高透氧型血小板贮存医用PVC材料，其特征在于，增塑剂选自DINCH、ATBC和TOTM的混合物，重量比为：DINCH∶ATBC∶TOTM＝1∶1.8～2.2∶0.5～0.8。
5.根据权利要求1或2所述的高透氧型血小板贮存医用PVC材料，其特征在于，所述的稳定剂为液体复配Ca/Zn稳定剂、环氧大豆油中的一种或几种；所述的润滑剂选自聚乙烯蜡、氯化聚乙烯蜡、硬脂酸或硅油的一种以上。
6.根据权利要求1～5任一项所述的高透氧型血小板贮存医用PVC材料的制备方法，其特征在于，包括如下步骤：
(1)预混料的制备，将各个物料在80～140℃预混，得预混料；
(2)挤出料的制备，将预混料加入双螺杆挤出机，在130～180℃进行塑化挤出造粒，制得所述高透氧性血小板贮存袋材料的粒料。
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| CN105038017A (zh) * | 2015-07-24 | 2015-11-11 | 南通慧源塑胶有限公司 | 一种医用薄膜材料 |
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