CN108939172B - 一种用于一次性子宫探针的可降解材料 - Google Patents
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Abstract
本发明涉及一种用于一次性子宫探针的可降解材料,属于可降解医用材料技术领域。为了解决现有的不能兼具耐腐蚀和抗菌的问题,提供一种用于一次性子宫探针的可降解材料,该材料包括以下重量份的成分:接枝聚L‑乳酸:75~78;聚已内酯:21~25;润滑剂:3.0~4.0;具有核壳结构的改性剂:4.0~5.0,所述改性剂的壳层为聚D‑乳酸和聚异戊二烯的混合物,核层为海藻酸钠和低聚壳聚糖,且所述海藻酸钠占改性剂的质量为4.0%~6.0%;所低聚壳聚糖占改性剂的质量为0.5%~0.8%;所述接枝聚L‑乳酸由含有环氧基的分子接枝而成。本发明整体上实现兼具降解性能好且具有耐腐蚀和抑菌的性能效果。
Description
技术领域
本发明涉及一种用于一次性子宫探针的可降解材料,属于可降解医用材料技术领域。
背景技术
子宫探针是妇科检查中常用的妇科检查器械,随着医学技术的不断发展,目前对于子宫探针的使用基本上是采用一次性子宫探针,杜绝交叉感染,提高使用的安全性和健康要求。但是,对于塑料性的一次性子宫探针是妇科常用的耗材,使用量也非常大,这就会涉及到使用后的集中处理问题,而一般性的塑料在焚烧等处理时由于不可降解性会导致环境的污染和损害人类的健康,而为了解决不可降解的问题,现有的也有采用一次性可降解的材料,如中国专利(授权公告号:102727940B)公开的一种降解型一次性子宫探针,采用聚乳酸、增强剂和润滑剂复合材料加工而成。但是,其仅是考虑了材料的可降解性,而由于子宫探针的应用环境的影响,在使用的过程中可能会受到尿酸等环境的影响而必须要具有较好的耐腐蚀性以及材料的抗菌性能,也就是现有的不能同时兼具降解、耐腐蚀和抗菌的性能。
发明内容
本发明针对以上现有技术中存在的缺陷,提供一种用于一次性子宫探针的可降解材料,解决的问题是如何实现兼具可降解、耐腐蚀和抗菌的性能。
本发明的目的是通过以下技术方案得以实现的,一种用于一次性子宫探针的可降解材料,该材料包括以下重量份的成分:
接枝聚L-乳酸:75~78;聚己内酯:21~25;润滑剂:3.0~4.0;具有核壳结构的改性剂:4.0~5.0,所述改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,核层为海藻酸钠和低聚壳聚糖,且所述海藻酸钠占改性剂的质量为4.0%~6.0%;所低聚壳聚糖占改性剂的质量为0.5%~0.8%;所述接枝聚L-乳酸由含有环氧基的分子接枝而成。
本发明采用的基材材料接枝聚L-乳酸和聚己内酯具有很好的生物可降解性,使材料整体具有较好降解能力,接枝聚L-乳酸和改性剂的壳层中的聚D-乳酸之间能够形成立构结晶的能力,以及接枝基团上的环氧基分子能够提高立构结晶的能力,从而使材料具有较好的热力学性能,而通过将海藻酸钠和低聚壳聚糖预先包裏在壳核内,能够使它们与基体材料之间具有较好的相容性,而海藻酸钠的加入能够使材料具有较好的耐酸性能来提高材料的耐腐蚀性,而低聚壳聚糖的加入目的是为了使材料具有一定的抗菌能力,避免使用过程中可能出现的细菌感染,从而使材料整体性实现兼具降解性能好且具有耐腐蚀和抑菌的性能效果。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述含有环氧基的分子选自甲基丙烯酸缩水甘油酯。通过采用接枝小分子,能够提高聚L-乳酸与聚D-乳酸之间的接触机率,有利于提高立构结晶的形成,使材料具有更优越的热力学性能。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述聚D-乳酸和聚异戊二烯的质量比为1:3~3.5。壳层中少量的聚D-乳酸来保证促进立构结晶的能力,而更多量的聚异戊二烯则能够使壳层具有较好的支撑能力和回弹性,提高力学形变能力,又能够使核层内的材料能够均匀的分布在内部形成核结构。作为更进一步的优选,所述聚异戊二烯为交联结构。提高双重的网络结构,提高材料性能和利用核层中的颗粒物在材料中的有效分布,来进一步的提高材料在耐腐蚀和抗菌活性方面的性能。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述低聚壳聚糖的分子量为5000~6000Da。对于低聚壳聚糖的抗菌活性能够与金属、微量元素和基本营养物质形成螯合物,从而能够限制微生物等细菌的生长而起到抑制作用。进一步的,经过长期的研究表明在添加低聚壳聚糖时对于其分子量若能作更优的要求,能够达到更佳的抑菌能力,在该范围内能够对金黄色葡萄球菌和大肠杆菌均具有较好的抑菌活性能力,抑菌率能够达到97%以上。而若分子量过小或过大反而不能同时兼具对这两种主要细菌的抑制活性。因此,在考虑同时抑制这两种细菌最好采用该范围内分子量的低聚壳聚糖。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述润滑剂为乙撑双硬脂酰胺。使材料在加工过程中具有较好的润滑性能,且能够使加工后的子宫探针也具有较好的润滑性。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述可降解材料中还包括2~3重量份的海藻糖。能够进一步的提高材料的抗菌活性能力,使具有更广泛的抗菌活性。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述可降解材料中还包括1~2重量份的抗氧化剂。提高材料的抗老化能力,使具有更长的保存时间。这里抗氧化剂采用一般的材料均可,并没有具体的限制要求。
在上述用于一次性子宫探针的可降解材料中,作为优选,所述可降解材料中还包括1~2重量份的6-苄氨基嘌呤铜配合物。目的在于提高采用的抗紫外能力,进一步的提高其抗老化性能。
综上所述,与现有技术相比,本发明具有以下优点:
通过本发明的可降解材料,尤其是通过将海藻酸钠和低聚壳聚糖预先包裏在壳核内,能够使它们与基体材料之间具有较好的相容性,从而使材料整体上实现兼具降解性能好且具有耐腐蚀和抑菌的性能效果。
具体实施方式
下面通过具体实施例和附图,对本发明的技术方案作进一步具体的说明,但是本发明并不限于这些实施例。
实施例1
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:78;聚己内酯:25;润滑剂乙撑双硬脂酰胺:3.0;具有核壳结构的改性剂:4.0,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为4.0%;低聚壳聚糖占改性剂的质量为0.5%,低聚壳聚糖的分子量为5000Da。
该一次性子宫探针的制作方法可以采用本领域常规的方法加工而成即可,本实施例中具体制备方法如下:
根据上述配方中可成分的重量比例选取原料,将经过干燥后的原料加入到造粒机中进行造粒成型,再将造粒成型后的复合材料颗粒物投入到注塑成型机中进行注塑成型,使注塑成型的温度在160℃~175℃,挤出速度在180转/分,注塑时间为4~10秒,得到相应的一次性子宫探针。子宫探针的规格可以根据实际需要进行选择
实施例2
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:75;聚己内酯:25;润滑剂乙撑双硬脂酰胺:4.0;具有核壳结构的改性剂:5.0,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.5,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为6.0%;低聚壳聚糖占改性剂的质量为0.8%,低聚壳聚糖的分子量为6000Da。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例3
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:76;聚己内酯:23;润滑剂乙撑双硬脂酰胺:35;具有核壳结构的改性剂:4.5,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为5.0%;低聚壳聚糖占改性剂的质量为0.6%,低聚壳聚糖的分子量为5500Da。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例4
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:77;聚己内酯:24;润滑剂乙撑双硬脂酰胺:3.6;具有核壳结构的改性剂:4.3,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.2,这里使聚异戊二烯呈交联结构,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为4.5%;低聚壳聚糖占改性剂的质量为0.5%,低聚壳聚糖的分子量为5000Da。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例5
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:75;聚己内酯:21;润滑剂乙撑双硬脂酰胺:3.0;具有核壳结构的改性剂:5.0,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为5.0%;低聚壳聚糖占改性剂的质量为0.7%,低聚壳聚糖的分子量为6000Da,还含有2重量份的海藻糖。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例6
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:76;聚己内酯:23;润滑剂乙撑双硬脂酰胺:3.0;具有核壳结构的改性剂:5.0,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.4,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为4.0%;低聚壳聚糖占改性剂的质量为0.8%,低聚壳聚糖的分子量为5000Da,还含有3重量份的海藻糖。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例7
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:76;聚己内酯:22;润滑剂乙撑双硬脂酰胺:3.5;具有核壳结构的改性剂:4.2,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.4,这里使聚异戊二烯呈交联结构,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为5%;低聚壳聚糖占改性剂的质量为0.6%,低聚壳聚糖的分子量为5000Da,海藻糖:2.5,抗氧剂:1,这里抗氧剂可采用抗氧剂1010等,6-苄氨基嘌呤铜配合物:1。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
实施例8
本实施例中的用于子宫探针的可降解材料包括以下成分的重量份:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:78;聚己内酯:21;润滑剂乙撑双硬脂酰胺:3.5;具有核壳结构的改性剂:4.2,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3,这里使聚异戊二烯呈交联结构,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为5%;低聚壳聚糖占改性剂的质量为0.5%,低聚壳聚糖的分子量为6000Da,海藻糖:2.8,抗氧剂:2,这里抗氧剂可采用抗氧剂1010等,6-苄氨基嘌呤铜配合物:2。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
比较例1
为了说明低聚壳聚糖的分子量对抗菌活性的影响,本比较例采用较大分子量的低聚壳聚糖。具体如下:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:77;聚己内酯:24;润滑剂乙撑双硬脂酰胺:3.6;具有核壳结构的改性剂:4.3,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.2,这里使聚异戊二烯呈交联结构,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为4.5%;低聚壳聚糖占改性剂的质量为0.5%,低聚壳聚糖的分子量为7000Da。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
比较例2
为了说明低聚壳聚糖的分子量对抗菌活性的影响,本比较例采用较小分子量的低聚壳聚糖。具体如下:
甲基丙烯酸缩水甘油酯接枝聚L-乳酸:77;聚己内酯:24;润滑剂乙撑双硬脂酰胺:3.6;具有核壳结构的改性剂:4.3,改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,这里,聚D-乳酸与聚异戊二烯的质量比为1:3.2,这里使聚异戊二烯呈交联结构,核层为海藻酸钠和低聚壳聚糖,且海藻酸钠占改性剂的质量为4.5%;低聚壳聚糖占改性剂的质量为0.5%,低聚壳聚糖的分子量为4000Da。
该一次性子宫探针的制作方法同实施例1一致,这里不再赘述。
随机选取上述实施例得到的相应复合材料进行相应的性能进行相应的测试,具体测试结果如下表1所示:
表1:
从上述表1中可以看出,本发明的复合材料具有较好的韧性(拉伸强度)和生物降解率,且具有较好的耐热性能。且本发明实施例1得到的相应产品对大肠杆菌和金黄色葡萄球菌均具有较好的抑菌性能,抑菌率均能够达到96%以上。本发明实施例1-4得到的相应产品对大肠杆菌和金黄色葡萄球菌均具有较好的抑菌性能,抑菌率均能够达到96%以上,而实施例5-8中由于另外添加了少量的海藻糖,其抑制活性有进一步的提高,使对大肠杆菌和金黄色葡萄球菌均具有较好的抑菌性能,抑菌率均能够达到98%以上,相当于能够提高一个较大的上升区间,而对于比较例1和比较例2而言,其反而不是同时大肠杆菌和金黄色葡萄球菌同时兼具较好的抑制能力,如比较例1中得到的相应产品,其对大肠杆菌的抑菌率只能达到85%左右,而对金黄色葡萄球菌的抑菌率则在95%左右,而比较例2中也只能达到相应的性能,其对大肠杆菌的抑菌率只能达到83%左右,而对金黄色葡萄球菌的抑菌率则在92%左右。同时进行相应的腐蚀性能测试,结果表明本发明的实施例1-8得到的相应产品均具有较好的耐腐蚀性能。
本发明中所描述的具体实施例仅是对本发明精神作举例说明。本发明所属技术领域的技术人员可以对所描述的具体实施例做各种各样的修改或补充或采用类似的方式替代,但并不会偏离本发明的精神或者超越所附权利要求书所定义的范围。
尽管对本发明已作出了详细的说明并引证了一些具体实施例,但是对本领域熟练技术人员来说,只要不离开本发明的精神和范围可作各种变化或修正是显然的。
Claims (9)
1.一种用于一次性子宫探针的可降解材料,其特征在于,该材料包括以下重量份的成分:
接枝聚L-乳酸:75~78;聚己内酯:21~25;润滑剂:3.0~4.0;具有核壳结构的改性剂:4.0~5.0,所述改性剂的壳层为聚D-乳酸和聚异戊二烯的混合物,核层为海藻酸钠和低聚壳聚糖,且所述海藻酸钠占改性剂的质量为4.0%~6.0%;所述低聚壳聚糖占改性剂的质量为0.5%~0.8%;所述接枝聚L-乳酸由含有环氧基的分子接枝而成。
2.根据权利要求1所述用于一次性子宫探针的可降解材料,其特征在于,所述含有环氧基的分子选自甲基丙烯酸缩水甘油酯。
3.根据权利要求1所述用于一次性子宫探针的可降解材料,其特征在于,所述聚D-乳酸和聚异戊二烯的质量比为1:3~3.5。
4.根据权利要求3所述用于一次性子宫探针的可降解材料,其特征在于,所述聚异戊二烯为交联结构。
5.根据权利要求1或2或3或4所述用于一次性子宫探针的可降解材料,其特征在于,所述低聚壳聚糖的分子量为5000~6000Da。
6.根据权利要求1或2或3所述用于一次性子宫探针的可降解材料,其特征在于,所述润滑剂为乙撑双硬脂酰胺。
7.根据权利要求1或2或3所述用于一次性子宫探针的可降解材料,其特征在于,所述可降解材料中还包括2~3重量份的海藻糖。
8.根据权利要求1或2或3所述用于一次性子宫探针的可降解材料,其特征在于,所述可降解材料中还包括1~2重量份的抗氧化剂。
9.根据权利要求8所述用于一次性子宫探针的可降解材料,其特征在于,所述可降解材料中还包括1~2重量份的6-苄氨基嘌呤铜配合物。
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CN104744902A (zh) * | 2013-12-31 | 2015-07-01 | 上海林静医疗器械有限公司 | 环保降解一次性医疗器械基材及制造方法 |
CN105504710A (zh) * | 2015-12-11 | 2016-04-20 | 安徽省中日农业环保科技有限公司 | 一种可耐酸碱擦拭的复合汽车内饰件材料及其制备方法 |
CN106589872A (zh) * | 2016-12-23 | 2017-04-26 | 浙江海正生物材料股份有限公司 | 一种高强耐热聚乳酸组合物 |
CN108117728A (zh) * | 2018-01-12 | 2018-06-05 | 浙江海正生物材料股份有限公司 | 一种可降解薄膜用耐热聚乳酸树脂组合物及其制备方法 |
CN108939172A (zh) * | 2018-08-13 | 2018-12-07 | 瞿向东 | 一种用于一次性子宫探针的可降解材料 |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN101684164A (zh) * | 2008-09-26 | 2010-03-31 | 杜小青 | 低聚壳聚糖的制备方法 |
CN102382435A (zh) * | 2010-08-30 | 2012-03-21 | 陈金福 | 生质复合材料组成物及其发泡方法 |
CN104744902A (zh) * | 2013-12-31 | 2015-07-01 | 上海林静医疗器械有限公司 | 环保降解一次性医疗器械基材及制造方法 |
CN105504710A (zh) * | 2015-12-11 | 2016-04-20 | 安徽省中日农业环保科技有限公司 | 一种可耐酸碱擦拭的复合汽车内饰件材料及其制备方法 |
CN106589872A (zh) * | 2016-12-23 | 2017-04-26 | 浙江海正生物材料股份有限公司 | 一种高强耐热聚乳酸组合物 |
CN108117728A (zh) * | 2018-01-12 | 2018-06-05 | 浙江海正生物材料股份有限公司 | 一种可降解薄膜用耐热聚乳酸树脂组合物及其制备方法 |
CN108939172A (zh) * | 2018-08-13 | 2018-12-07 | 瞿向东 | 一种用于一次性子宫探针的可降解材料 |
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