CN107892891A - 一种用于医用电极片的导电压敏胶及其制备方法 - Google Patents
一种用于医用电极片的导电压敏胶及其制备方法 Download PDFInfo
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- CN107892891A CN107892891A CN201710311078.9A CN201710311078A CN107892891A CN 107892891 A CN107892891 A CN 107892891A CN 201710311078 A CN201710311078 A CN 201710311078A CN 107892891 A CN107892891 A CN 107892891A
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- Prior art keywords
- pressure sensitive
- sensitive adhesive
- conductive pressure
- electro
- pole piece
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Abstract
本发明是一种用于医用电极片的导电压敏胶,其质量百分比组分包括:光固化单体10~50%、可聚合表面活性剂0.5~30%、电解质0.2~2.5%、氢氧化钠0.2~1.5%、蒸馏水10~50%、聚乙二醇1~20%、甘油5~30%、消泡剂0.05~1%和UV光引发剂0.02~2%。本发明的医用导电压敏胶保持膜结构的完整性,解决了常规的压敏胶中出现的干涸、贮藏时间短、粘结性能衰减快等缺陷,同时具有对人体皮肤优异的粘结强度、储存稳定性、良好模切及生物兼容性能。本医用导电压敏胶可以用于一次性使用心电电极、理疗电极、高频电刀用板电极等医疗器械行业。
Description
技术领域
本发明涉及功能性胶黏剂,尤其涉及一种具有优良粘结性能、离子导电性能及生物相容性的医用压敏胶及其制备方法。
背景技术
目前医学诊断治疗大多通过将可传递电流信号的导电电极片粘附于病人皮肤表面与医用设备连接,从而达到采集人体内电信号目的。常见的案例如用于诊断、监测心脏活动异常的心电图扫描、经皮神经电刺激疗法、神经肌肉电刺激治疗技术等,都要用到医用电极片这一关键器件。
医用电极片通常是由PET载膜、Ag/AgCl导电油墨印刷层、离子导电压敏胶及离型膜构成。在电极对上施加峰值100μA的10Hz正弦交流电流的情况下,电极对的交流阻抗不超过2KΩ;组成电极对后,经过1min稳定期,电极对的直流失调电压不大于100mV;组成电极对后,经过1min稳定期,在随后的5min后,电极对在0.15-100Hz的频带(一阶频率响应)中产生的内部噪音的峰值不大于150μA;电极对经过400nA的直流电流持续作用4h,在整个作用期间内电极对两端的电压变化不大于100mV。
微乳是由水-油相中在起稳定作用的表面活性剂下按适当比例混合,自发形成的一种透明或半透明的,各向同性且热力学稳定的分散体系。微乳液液滴可以是分散在水中的油溶胀粒子(O/W微乳液)也可以是分散在油中的水溶胀粒子(W/O)微乳液)或是一种无序的随机结构。微乳液是10纳米左右的单一球形液滴,因此体系具有光学透明性.此时的液滴可以是O/W型,也可以是W/O型,在中间区域,微乳液呈双连续结构。
与传统乳液聚合不同,微乳液粒径为8-80nm,属于纳米级微粒,经特殊表面活性剂体系保护可成为热力学稳定体系,各向同性,清亮透明。而传统乳液聚合最终乳胶粒粒径为100-150nm,乳液不透明,呈乳白色,属于热力学不稳定体系。
虽然在常规心电图体检中医用电极片粘附于人体皮肤时间只有短到几分钟,但对那些重症病人则需要几天甚至更长期地监测其生理指标。而对于多毛性皮肤或出汗严重的皮肤患者,无论哪种情形,都可能造成因医用电极片未能恰当地粘附于人体皮肤而产生误导性的假电流信号。造成这一现象的主要原因是由于常规的医用压敏胶浸润性及对抗湿气环境差,从而减弱了粘结性能。更主要的是常规的乳液聚合技术中使用的表面活性剂不是以牢固的共价键键合而只是吸附到高分子膜材料上,容易从胶乳粒子表面解吸下来,迁移到膜表面,形成聚集体而降低产品的耐水性,导致医用电极片上的压敏胶粘性大大降低。
发明内容
本发明所要解决的技术问题是,克服现有技术的缺点,提供一种用于医用电极片的导电压敏胶,通过光聚合微乳法制备高粘结强度医用导电胶,通过加入可聚合表面活性剂改变反应物原料,制备的导电压敏胶具有对人体皮肤优异的粘结强度、储存稳定性、良好模切及生物兼容性能。
本发明解决以上技术问题的技术方案是:
一种用于医用电极片的导电压敏胶,其质量百分比组分包括:光固化单体10~50%、可聚合表面活性剂0.5~30%、电解质0.2~2.5%、氢氧化钠0.2~1.5%、蒸馏水10~50%、聚乙二醇1~20%、甘油5~30%、消泡剂0.05~1%和UV光引发剂0.02~2%。
用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
㈠将光固化单体、UV光引发剂、可聚合表面活性剂、消泡剂和聚乙二醇加入反应容器A中,搅拌溶解混合,形成微乳反应物A;
㈡将电解质、氢氧化钠、蒸馏水、可聚合表面活性剂和甘油加入反应容器B中,搅拌溶解混合,形成微乳反应物B步骤㈠和㈡中可聚合表面活性剂的加入量比例为:步骤㈠:步骤㈡=1~4:4~1;
㈢将所述微乳反应物A和B混合在一起,搅拌后得到热力学稳定的微乳体系透明溶液;
㈣将所述微乳体系透明溶液涂覆于两层PET离型膜膜片之间,通过UV光照射得到医用导电压敏胶。
这样,本发明的导电压敏胶通过紫外光聚合反应制得,形成以纳米级微乳体系的两相结构:第一相包含亲水性聚合物、电解质水溶液、甘油等;(第二相包含疏水性聚合物;其中第一相为连续相,第二相为区域相,均匀分散于第一相中,两相以交叉网络共存构成压敏胶膜;这样的结构可大大提高压敏胶粘性,具有对人体皮肤优异的粘结强度、储存稳定性、良好模切及生物兼容性能,且能够形成有效的水溶液离子电解质导电通路,从而保证导电压敏胶用于电极对后的的低交流阻抗;根据GB2792-1998测试标准,在玻璃板表面的平均剥离强度至少达到1000gf/25mm。通过光聚合形成医用导电压敏胶,可聚合表面活性剂的使用减少甚至抑制表面活性剂向膜表面或膜内亲水性区域的迁移,从而维持医用导电压敏胶在整个储存、使用过程中的高粘结性能。
本发明进一步限定的技术方案是:
前述的用于医用电极片的导电压敏胶,可聚合表面活性剂为ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯、ω-(1-壬基酚甲基-2-(2-丙氧基)乙氧基)-聚氧乙烯硫酸铵、2-丙烯酰胺基-2-甲基丙磺酸钠、丙烯酰胺烷基磺酸钠、丙烯酰化失水山梨醇单硬脂酸酯、马来酸酐十二醇聚氧乙烯醚单酯钠盐中的一种或多种组合。
前述的用于医用电极片的导电压敏胶中可聚合表面活性剂ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯的制备,包括下列步骤:
⑴在0℃下,将60-70毫升的3,4-二氢-2H-吡喃(DHP)滴加入由40-60克11-溴-1-十一醇和0.3-0.6克对甲苯磺酸的四氢呋喃90-100毫升溶液中持续搅拌1-2h,常温静置10-13小时;通过旋转蒸发将四氢呋喃和过量的3,4-二氢-2H-吡喃除去,残留物溶于100-200毫升乙醚后,用饱和溴水清洗至少一次除去对甲苯磺酸,有机相用无水硫酸镁干燥及过滤,将乙醚蒸除,得二氢吡喃-11-溴十一烷基醚;
⑵将20-30克二氢吡喃-11-溴十一烷基醚与5-7克KOH细粉在持续搅拌下,加入到150-250毫升体积比为1:1的四氢呋喃和苯混合溶剂的50-60克聚乙二醇甲醚溶液中,反应混合物在氮气保护下持续搅拌20-25小时后过滤,蒸除四氢呋喃和苯溶剂,残留物用乙醚洗除过量的二氢吡喃-11-溴十一烷基醚,得到白色沉淀物,再经过0℃下乙醚冲洗后,溶于氯仿,该溶液经无水硫酸镁干燥过夜后过滤,将氯仿蒸除,即得二氢吡喃-ω-甲氧基聚氧化乙烯十一烷基醚;
⑶将15-25克二氢吡喃-ω-甲氧基聚氧化乙烯十一烷基醚溶于酸化乙醇,pH值达到2.5-3.5后,在油浴中搅拌回流3-5小时,蒸除甲醇后的残留物溶于氯仿,用饱和溴水清洗至少一次,经无水硫酸镁干燥后过滤,将氯仿蒸除,即得ω-甲氧基聚氧化乙烯十一醇;
⑷将20-30克ω-甲氧基聚氧化乙烯十一醇和7-10毫升三乙胺滴加到含有4-7毫升甲基丙烯酰氯的70-90毫升无水乙醇溶液中,氮气保护并维持0℃下30min-60min,形成固体盐,室温下搅拌,除去过量的甲基丙烯酰氯、三乙胺和无水乙醇后,残留物溶于氯仿,用饱和碳酸氢钠溶液和饱和溴水清洗至少一次,将氯仿蒸除,即得ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯。
本发明加入可聚合表面活性剂,如ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯,可将C-C双键引入到表面活性剂分子结构中,使其在微乳聚合过程中永久地键接到高分子膜链中,从而解决表面活性剂解吸问题,稳定性更好。本发明的可聚合表面活性剂,通过纳米级微乳体系双连续结构体系制得的压敏胶,可广泛用于诊断、理疗、电外科器械以及其它医疗目的中的生物医用电极;在其基本构成中,它是作为一个连接生物皮肤与电子诊断、治疗、电外科器械之间电子通讯的导电媒介;如生物医用电极在诊断、治疗过程中,用于疼痛治疗的经皮神经电刺激(TENS)器械、脊柱侧弯治疗的神经肌肉刺激(NMS)以及检测心跳和心脏异常的心电图(EKG)。
前述的用于医用电极片的导电压敏胶,其中UV光引发剂为2-羟基-2-甲基-1-苯基丙酮、1-羟基环己基苯基甲酮、2-甲基-2-(4-吗啉基)-1-[4-(甲硫基)苯基]-1-丙酮、2,4,6-三甲基苯甲酰基-二苯基氧化膦、2,4,6-三甲基苯甲酰基苯基膦酸乙酯、2-二甲氨基-2-苄基-1-[4-(4-吗啉基)苯基]-1-丁酮、2-羟基-2-甲基-1-[4-(2-羟基乙氧基)苯基]-1-丙酮、苯甲酰甲酸甲酯、安息香、安息香双甲醚、安息香乙醚、芳酰基膦氧化物、双苯甲酰基苯基氧化膦、2,4-二羟基二苯甲酮、硫代丙氧基硫杂蒽酮、异丙基硫杂蒽酮中一种或多种组合。
前述的用于医用电极片的导电压敏胶,其中光固化单体为丙烯酸、甲基丙烯酸、2-丙烯酰胺-2-甲基丙磺酸、N,N-二甲基丙烯酰胺、β羧乙基丙烯酸酯、丙烯酸-2-乙基己酯、丙烯酸丁酯、N-乙烯基吡咯烷酮、3,3,5-三甲基环己烷甲基丙烯酸酯、甲氧基聚乙二醇单甲基丙烯酸酯、甲氧基聚乙二醇单丙烯酸酯、烷氧基十二烷基丙烯酸酯、四氢呋喃甲基丙烯酸酯、脂环族丙烯酸、十二烷基甲基丙烯酸酯、硬脂丙烯酸甲酯、丙烯酸异葵酯、甲基丙烯酸异冰片酯、丙烯酸辛酯、丙烯酸己内酯、三羟甲基丙烷缩甲醛丙烯酸酯、环己烷二甲醇二丙烯酸酯、二缩三乙二醇二甲基丙烯酸酯、乙二醇二甲基丙烯酸酯、1,4-丁二醇二甲基丙烯酸酯、1,6-己二醇二丙烯酸酯、聚乙二醇二丙烯酸酯、四甘醇二丙烯酸酯、二缩三丙二醇二丙烯酸酯、三环葵烷二甲醇二丙烯酸酯、丙氧化新戊二醇二丙烯酸酯、三羟甲基丙烷三甲基丙烯酸酯、三羟甲基丙烷三丙烯酸酯、乙氧化三羟甲基丙烷三丙烯酸酯、季戊四醇三丙烯酸酯、丙氧化丙三醇三丙烯酸酯、二季戊四醇六丙烯酸酯、季戊四醇四丙烯酸酯、二-三羟甲基丙烷四丙烯酸酯、二季戊四醇五丙烯酸酯中的一种或多种组合。
前述的用于医用电极片的导电压敏胶,其中消泡剂为苯乙醇油酸酯、苯乙酸月桂醇酯、GP型消泡剂、GPE型消泡剂、GPES型消泡剂、聚二甲基硅氧烷、聚醚改性硅中的一种。
前述的用于医用电极片的导电压敏胶,其中电解质为LiCl、KCl、NaCl或NH4Cl中的一种或多种组合。
前述的用于医用电极片的导电压敏胶,其中聚乙二醇为聚乙二醇200、聚乙二醇300、聚乙二醇400、聚乙二醇600、聚乙二醇1000、聚乙二醇1500中的一种或多种组合。前述的用于医用电极片的导电压敏胶的制备方法,其中微乳反应物A和B混合在一起,搅拌后静置1~2小时;将所述微乳体系透明溶液涂覆于两层PET离型膜膜片之间,通过UV光下照射1~10分钟。
本发明的有益效果是:⑴微乳液光聚合制得的导电压敏胶具有双连续结构,能够形成有效的水溶液离子电解质导电通路,从而保证导电压敏胶用于电极对后的的低交流阻抗;⑵可聚合表面活性剂,特别是ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯,将C-C双键引入到表面活性剂分子结构中,使其在微乳聚合过程中永久地键接到高分子膜链中,从而解决表面活性剂解吸问题,稳定性更好;⑶光聚合形成医用导电压敏胶时,可聚合表面活性剂的使用减少甚至抑制表面活性剂向膜表面或膜内亲水性区域的迁移,从而维持医用导电压敏胶在整个储存、使用过程中的高粘结性能;⑷胶乳光聚合成膜时,部分包埋的表面活性剂可作为聚结剂改进所形成的导电压敏胶膜的性能,时其更利于模切中的排废工艺,减轻溢胶现象发生;⑸本发明的医用导电压敏胶保持膜结构的完整性,解决了常规的压敏胶中出现的干涸、贮藏时间短、粘结性能衰减快等缺陷。
附图说明
图1是本本发明医用电极片示意图。
图2是本发明医用电极片剖面结构示意图。
图3是本发明中三组份相图。
具体实施方式
实施例1
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将7.2%甲基丙烯酸、22.5%β羧乙基丙烯酸酯、3.2%N,N-二甲基丙烯酰胺、0.6%1-羟基环己基苯基甲酮、8.5%ω-甲氧基聚氧化乙烯十一醇-α-甲基丙烯酸酯、0.5%聚二甲基硅氧烷、5.9%聚乙二醇400和6.2%聚乙二醇600加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将1.9%KCl、0.6%NaOH、18.2%蒸馏水、10.6%ω-甲氧基聚氧化乙烯十一醇-α-甲基丙烯酸酯和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为503.8mJ/cm2下,固化5分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
实施例2
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将10.7%甲基丙烯酸异冰片酯、26.1%N-乙烯基吡咯烷酮、0.8%丙氧化新戊二醇二丙烯酸酯、0.7%2-羟基-2-甲基-1-苯基丙酮、5.6%ω-甲氧基聚氧化乙烯十一醇-α-甲基丙烯酸酯、0.3%GP型消泡剂、10.2%聚乙二醇200和1.3%聚乙二醇1500加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将1%NaCl、0.5%NaOH、20.5%蒸馏水、13.6%2-丙烯酰胺基-2-甲基丙磺酸钠和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为310.9mJ/cm2下,固化8分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
实施例3
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将7.2%甲基丙烯酸、24.8%丙烯酸2-乙基己酯、0.5%环己烷二甲醇二丙烯酸酯、0.8%2-羟基-2-甲基-1-[4-(2-羟基乙氧基)苯基]-1-丙酮、8.9%ω-(1-壬基酚甲基-2-(2-丙氧基)乙氧基)-聚氧乙烯硫酸铵、0.4%苯乙醇油酸酯、11.3%聚乙二醇300和4.8%聚乙二醇1000加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将0.9%LiCl、0.3%NaOH、20.6%蒸馏水、12.6%ω-甲氧基聚氧化乙烯十一醇-α-甲基丙烯酸酯和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为380.2mJ/cm2下,固化10分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
实施例4
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将9.1%丙烯酸、30.6%丙烯酸丁酯、0.3%三羟甲基丙烷三丙烯酸酯、0.7%苯甲酰甲酸甲酯、10.6%2-丙烯酰胺基-2-甲基丙磺酸钠、0.2%GPES型消泡剂、5%聚乙二醇200和4.6%聚乙二醇1000加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将1.1%NH4Cl、0.9%NaOH、19.6%蒸馏水、9.1%丙烯酰胺烷基磺酸钠和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为615.4mJ/cm2下,固化2分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
实施例5
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将8.7%丙烯酸、31.4%丙烯酸辛酯、0.5%二缩三丙二醇二丙烯酸酯、0.3%双苯甲酰基苯基氧化膦、9.6%马来酸酐十二醇聚氧乙烯醚单酯钠盐、0.1%苯乙酸月桂醇酯、7.3%聚乙二醇300和4.6%聚乙二醇1500加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将0.7%KCl、0.9%NaOH、20.8%蒸馏水、7.2%丙烯酰化失水山梨醇单硬脂酸酯和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为487.3mJ/cm2下,固化3分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
实施例6
本发明是一种用于医用电极片的导电压敏胶的制备方法,包括以下步骤:
(1)、将4.8%丙烯酸、32.5%丙烯酸2-乙基己酯、1.7%N,N-二甲基丙烯酰胺、0.2%1,6-己二醇二丙烯酸酯、0.3%2,4,6-三甲基苯甲酰基-二苯基氧化膦、8.2%ω-甲氧基聚氧化乙烯十一醇-α-甲基丙烯酸酯、0.08%聚醚改性硅、6.3%聚乙二醇400和5.0%聚乙二醇600加入反应容器A中,高速搅拌溶解混合,形成微乳反应物A;
(2)、将1.2%KCl、0.8%NaOH、24.1%蒸馏水、6.1%丙烯酰胺烷基磺酸钠和余量的甘油加入反应容器B中,高速搅拌溶解混合,形成微乳反应物B;
(3)、将上述形成的微乳反应物A、B混合在一起,高速搅拌后静置1~2小时,即得到热力学稳定的微乳体系透明溶液;
(4)、将步骤(3)透明溶液涂覆于两层PET离型膜膜片之间,在UV波长390nm,强度为513.2mJ/cm2下,固化6分钟,即得到医用导电压敏胶。
(5)、将上述导电压敏胶和印刷导电油墨PET膜通过双辊轮加压贴合,检测外观,保证无气泡,随后进行性能测试。
导电压敏胶电性能测试方法:
Xtratek ET-65A ECG电极测试仪用于交流阻抗测试,连接方式:电极对以胶面-胶面的方式粘接,用低水平信号,频率为10Hz的条件记录阻抗。参考标准;美国国家标准预凝胶型ECG一次性电极(美国医疗仪器促进协会(AAMI)),交流阻抗低于2kΩ,除颤过载恢复小于100mV(在4次电容放电,残余极化电位变化率不大于1mV/sec下5秒后)被认为是人体皮肤可接受水平。
导电压敏胶初粘力:
导电压敏胶初粘力根据美国测试材料协会ASTM D2979规范,通过探头式初粘仪PT-1000(ChemInstrument)测定。直径为5mm平面探头,以61公分/分的速度与胶面接触后自动停留一秒钟就回头上拉,仪器自动记录离开压敏胶的最大拉力,即为初粘力。
导电压敏胶剥离强度:
导电压敏胶根据国家标准GB/T 2792—1998,用拉力试验机测定导电压敏胶黏带在玻璃板表面180°剥离强度。
以商品化产品作对比,其测试结果一并列入下表1:
表1
由以上表1可得知:本发明导电压敏胶体系具有与现有产品相匹配的交流阻抗及除颤过载恢复等电性能外,其反映粘结性能的初粘力,特别是剥离强度显著改善,表明以此制得的导电电极片在患者皮肤表面的附着性明显提高。
图1和2分别是一个用于心电图(EKG)检测或经皮神经电刺激(TENS)器械的医用电极片外貌和剖面结构示意图。导电电极片1经过模切加工成型于PET离型膜2,并以卷材形式储存。使用时,导电电极片1从PET离型膜2剥下,贴附于患者皮肤表面,连接检测器械的剪型电接头3夹在没有附胶的导电油墨层5一端。典型的一次性医用导电电极片是一个厚度为0.2-0.8mm的膜块材料,如一面印刷5um左右Ag/AgCl导电油墨5的PET载膜4,其大部分长方形区域与具有生物兼容性的导电压敏胶6贴合,留出的耳部区域用于连接剪型电接夹头3。
图3是本发明体系中的三组份相图,阴影区为本发明实施例中组份覆盖区,作为合成导电压敏胶前体的微乳体系,其中每一组组份都会在相图中找到对应的点,从而得知热力学稳定性能。在下列实施例中组份的构成全部落于图中阴影区,表明本发明配方属于热力学稳定体系,有利于生产涂布及储存稳定性。
除上述实施例外,本发明还可以有其他实施方式。凡采用等同替换或等效变换形成的技术方案,均落在本发明要求的保护范围。
Claims (10)
1.一种用于医用电极片的导电压敏胶,其特征在于:其质量百分比组分包括:光固化单体10~50%、可聚合表面活性剂0.5~30%、电解质0.2~2.5%、氢氧化钠0.2~1.5%、蒸馏水10~50%、聚乙二醇1~20%、甘油5~30%、消泡剂0.05~1%和UV光引发剂0.02~2%。
2.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的可聚合表面活性剂为ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯、ω-(1-壬基酚甲基-2-(2-丙氧基)乙氧基)-聚氧乙烯硫酸铵、2-丙烯酰胺基-2-甲基丙磺酸钠、丙烯酰胺烷基磺酸钠、丙烯酰化失水山梨醇单硬脂酸酯、马来酸酐十二醇聚氧乙烯醚单酯钠盐中的一种或多种组合。
3.如权利要求2所述的用于医用电极片的导电压敏胶,其特征在于:所述ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯的制备,包括下列步骤:
⑴在0℃下,将60-70毫升的3,4-二氢-2H-吡喃(DHP)滴加入由40-60克11-溴-1-十一醇和0.3-0.6克对甲苯磺酸的四氢呋喃90-100毫升溶液中持续搅拌1-2h,常温静置10-13小时;通过旋转蒸发将四氢呋喃和过量的3,4-二氢-2H-吡喃除去,残留物溶于100-200毫升乙醚后,用饱和溴水清洗至少一次除去对甲苯磺酸,有机相用无水硫酸镁干燥及过滤,将乙醚蒸除,得二氢吡喃-11-溴十一烷基醚;
⑵将20-30克二氢吡喃-11-溴十一烷基醚与5-7克KOH细粉在持续搅拌下,加入到150-250毫升体积比为1:1的四氢呋喃和苯混合溶剂的50-60克聚乙二醇甲醚溶液中,反应混合物在氮气保护下持续搅拌20-25小时后过滤,蒸除四氢呋喃和苯溶剂,残留物用乙醚洗除过量的二氢吡喃-11-溴十一烷基醚,得到白色沉淀物,再经过0℃下乙醚冲洗后,溶于氯仿,该溶液经无水硫酸镁干燥过夜后过滤,将氯仿蒸除,即得二氢吡喃-ω-甲氧基聚氧化乙烯十一烷基醚;
⑶将15-25克二氢吡喃-ω-甲氧基聚氧化乙烯十一烷基醚溶于酸化乙醇,pH值达到2.5-3.5后,在油浴中搅拌回流3-5小时,蒸除甲醇后的残留物溶于氯仿,用饱和溴水清洗至少一次,经无水硫酸镁干燥后过滤,将氯仿蒸除,即得ω-甲氧基聚氧化乙烯十一醇;
⑷将20-30克ω-甲氧基聚氧化乙烯十一醇和7-10毫升三乙胺滴加到含有4-7毫升甲基丙烯酰氯的70-90毫升无水乙醇溶液中,氮气保护并维持0℃下30min-60min,形成固体盐,室温下搅拌,除去过量的甲基丙烯酰氯、三乙胺和无水乙醇后,残留物溶于氯仿,用饱和碳酸氢钠溶液和饱和溴水清洗至少一次,将氯仿蒸除,即得ω-甲氧基聚氧化乙烯十一醇α-甲基丙烯酸酯。
4.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的UV光引发剂为2-羟基-2-甲基-1-苯基丙酮、1-羟基环己基苯基甲酮、2-甲基-2-(4-吗啉基)-1-[4-(甲硫基)苯基]-1-丙酮、2,4,6-三甲基苯甲酰基-二苯基氧化膦、2,4,6-三甲基苯甲酰基苯基膦酸乙酯、2-二甲氨基-2-苄基-1-[4-(4-吗啉基)苯基]-1-丁酮、2-羟基-2-甲基-1-[4-(2-羟基乙氧基)苯基]-1-丙酮、苯甲酰甲酸甲酯、安息香、安息香双甲醚、安息香乙醚、芳酰基膦氧化物、双苯甲酰基苯基氧化膦、2,4-二羟基二苯甲酮、硫代丙氧基硫杂蒽酮、异丙基硫杂蒽酮中一种或多种组合。
5.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的光固化单体为丙烯酸、甲基丙烯酸、2-丙烯酰胺-2-甲基丙磺酸、N,N-二甲基丙烯酰胺、β羧乙基丙烯酸酯、丙烯酸-2-乙基己酯、丙烯酸丁酯、N-乙烯基吡咯烷酮、3,3,5-三甲基环己烷甲基丙烯酸酯、甲氧基聚乙二醇单甲基丙烯酸酯、甲氧基聚乙二醇单丙烯酸酯、烷氧基十二烷基丙烯酸酯、四氢呋喃甲基丙烯酸酯、脂环族丙烯酸、十二烷基甲基丙烯酸酯、硬脂丙烯酸甲酯、丙烯酸异葵酯、甲基丙烯酸异冰片酯、丙烯酸辛酯、丙烯酸己内酯、三羟甲基丙烷缩甲醛丙烯酸酯、环己烷二甲醇二丙烯酸酯、二缩三乙二醇二甲基丙烯酸酯、乙二醇二甲基丙烯酸酯、1,4-丁二醇二甲基丙烯酸酯、1,6-己二醇二丙烯酸酯、聚乙二醇二丙烯酸酯、四甘醇二丙烯酸酯、二缩三丙二醇二丙烯酸酯、三环葵烷二甲醇二丙烯酸酯、丙氧化新戊二醇二丙烯酸酯、三羟甲基丙烷三甲基丙烯酸酯、三羟甲基丙烷三丙烯酸酯、乙氧化三羟甲基丙烷三丙烯酸酯、季戊四醇三丙烯酸酯、丙氧化丙三醇三丙烯酸酯、二季戊四醇六丙烯酸酯、季戊四醇四丙烯酸酯、二-三羟甲基丙烷四丙烯酸酯、二季戊四醇五丙烯酸酯中的一种或多种组合。
6.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的消泡剂为苯乙醇油酸酯、苯乙酸月桂醇酯、GP型消泡剂、GPE型消泡剂、GPES型消泡剂、聚二甲基硅氧烷、聚醚改性硅中的一种。
7.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的电解质为LiCl、KCl、NaCl或NH4Cl中的一种或多种组合。
8.如权利要求1所述的用于医用电极片的导电压敏胶,其特征在于:所述的聚乙二醇为聚乙二醇200、聚乙二醇300、聚乙二醇400、聚乙二醇600、聚乙二醇1000、聚乙二醇1500中的一种或多种组合。
9.如权利要求1-8中任一权利要求所述的用于医用电极片的导电压敏胶的制备方法,其特征在于:包括以下步骤:
㈠将光固化单体、UV光引发剂、可聚合表面活性剂、消泡剂和聚乙二醇按配比加入反应容器A中,搅拌溶解混合,形成微乳反应物A;
㈡将电解质、氢氧化钠、蒸馏水、可聚合表面活性剂和甘油按配比加入反应容器B中,搅拌溶解混合,形成微乳反应物B;所述步骤㈠和㈡可聚合表面活性剂加入比为:步骤㈠:步骤㈡=1~4:4~1;
㈢将所述微乳反应物A和B混合在一起,搅拌后得到热力学稳定的微乳体系透明溶液;
㈣将所述微乳体系透明溶液涂覆于两层PET离型膜膜片之间,通过UV光照射得到医用导电压敏胶。
10.如权利要求8所述的用于医用电极片的导电压敏胶的制备方法,其特征在于:将所述微乳反应物A和B混合在一起,搅拌后静置1~2小时;将所述微乳体系透明溶液涂覆于两层PET离型膜膜片之间,通过UV光下照射1~10分钟。
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Application publication date: 20180410 |
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