CN107754009A - 一种过敏性低的高粘度水胶体的制备方法及使用方法 - Google Patents
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Abstract
本发明公开了一种过敏性低的高粘度水胶体的制备方法及使用方法,所述水胶体配方以热塑性弹性体为基材,松香树脂为增粘剂,羧甲基纤维素纳或交联‑羧甲基纤维素纳、变性淀粉、环糊精、聚乙烯醇为增稠剂,环烷油作为软化剂。热塑性弹性体具有热塑性、高弹性、熔融指数和溶液粘度低,与增粘树脂相容性好的特点,制成的产品柔性好、粘性强、能与许多增粘剂和增塑剂缔合而获得性能良好的瞬粘剂,是热熔胶和压敏胶中的一个重要品种。为达到某些功能,优选地,添加了抗氧化剂、骨胶、聚异丁烯、羧甲基壳聚糖、色素、蜂蜜、甘油、藻酸盐、各种蛋白、发泡剂、沸石、远红外陶瓷粉、发泡剂和药典中列明的各种中药制剂。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种过敏性低的高粘度水胶体的制备方法及使用方法。
背景技术
皮肤过敏是一种很常见的过敏形式,有20%的人有皮肤过敏现象。从医学角度讲,皮肤过敏主要是指当皮肤受到各种刺激而导致皮肤出现红肿、发痒、脱皮及过敏性皮炎等异常现象。皮肤过敏症状是发痒,同时也可能会伴有红肿干屑、水泡,或病灶结痂及渗出液化等症状;这些病灶的形状与大小各有不同。偶尔可能会发生胸部紧绷、麻木、肿胀等症状;当出现这些症状时,就是皮肤过敏了。其他皮肤过敏症状还包括发痒、打喷嚏、流鼻水、泪眼、皮疹、气道阻塞,或如荨麻疹等皮肤症状。在极罕见的情况下,过敏反应甚至可能会危及生命,例如一种称作过敏性休克症状。
水胶体敷料是在湿性愈合原理指导下发展起来的一类新型敷料,由弹性的聚合水凝胶与合成橡胶以及粘性物混合加工而成。其中最常见的凝胶为羟甲基纤维素,该凝胶可牢固地粘贴于创口边缘皮肤,当吸收渗液后可肿胀12倍。水胶体敷料含有以下特性:①具有吸收创面渗液的能力。吸收渗液后,敷料中的亲水性颗粒可形成类似凝胶的半固体物质,附着于伤口基部,提供并维持有利于创面愈合的湿性环境。②有粘性,可形成密闭(occlusive)创面。密闭的愈合环境能够促进微血管的增生和肉芽组织的形成,从而加速创面愈合。③可发挥清创功能。一方面,水胶体含有内源性的酶,能促进纤维蛋白的溶解;另一方面,水胶体敷料所提供的密闭环境,有利于巨噬细胞清除坏死组织。
水胶体敷料主要用于慢性伤口如压疮和静脉溃疡伤口的治疗。水胶体敷料也可用于急性伤口的护理。对于捐皮区(donor site)的创面,使用水胶体敷料治疗后的愈合时间要比传统治疗方法缩短约40%。水胶体敷料在表层伤口和手术创伤的治疗中也具有类似的有益效果。另外,在治疗烧伤时,水胶体敷料具有减轻患者疼痛的作用。
现有的一些水胶体表面张力低,粘度不高,容易发生移位,透气性不好,致敏性尚不明确。
发明内容
针对现有技术存在的一系列问题,本发明提供一种过敏性低的高粘度水胶体的制备方法及使用方法。本发明以热塑性弹性体为基质,并与松香树脂、羧甲基纤维素钠以及环烷油等混制成全新的过敏性低且粘度高的水胶体。
本发明的技术方案如下:
本发明的一种过敏性低的高粘度水胶体配方,按成分比例,特征在于:热塑性弹性体比例为10-47%,松香树脂比例为30-58%,增稠剂比例为1-60%,优选地,使用羧甲基纤维素纳比例为1-38%,环烷油的比例为5-30%。
所述热塑性弹性体为苯乙烯类(SBS、SIS、SEBS、SEPS)。
所述松香树脂为松香甲酯、松香乙烯醇酯或甘油酯。
所述增稠剂为羧甲基纤维素钠、交联羧甲基纤维素钠、变性淀粉、环糊精、聚乙烯醇。
所述水胶体初粘性>药典滚球法初粘性试验中的32号钢球。
为达到某些功能,可以添加抗氧化剂、骨胶、聚异丁烯、羧甲基壳聚糖、色素、蜂蜜、甘油、藻酸盐、各种蛋白、发泡剂、沸石、远红外陶瓷粉、发泡剂和药典中列明的各种中药制剂。本发明的优点是:采用此配方制得的水胶体既沿袭了传统水胶体敷料吸收渗液、维持湿性愈合环境、黏性适中以及不粘连患处等优点,又具有独特的抗敏性能和高粘度性能。
附图说明
下面结合附图和具体实施方式对本发明做进一步的详细说明:
图1是本发明实施例1一种过敏性低的高粘度水胶体配方的制备过程示意图。
具体实施方式
以下对本发明的具体实施方式进行详细说明。
实施例1~3
一种过敏性低的高粘度水胶体配方,由下列重量份数的组分组成:
名称 | 实施例1 | 实施例2 | 实施例3 |
苯乙烯类热塑性弹性体 | 80 | 0 | 80 |
聚氨酯类热塑性弹性体 | 0 | 80 | 0 |
松香树脂 | 30 | 30 | 17 |
羧甲基纤维素钠 | 50 | 50 | 50 |
环烷油 | 30 | 30 | 30 |
抗氧剂1010 | 5 | 5 | 5 |
所述过敏性低的高粘度水胶体通过一下步骤制得:
(1)将热塑性弹性体、软化剂加入反应炉内高温搅拌熔炼,熔炼温度控制在120℃-180℃,搅拌速度在20rpm-80rpm,时间为0.5-6小时;然后,依次添 加增粘树脂、增稠剂、防老剂和权利要求中所述的功能性材料,继续搅拌0.5-2小时。搅拌总时间为1-8小时,期间温度控制在40℃-180℃左右;最后,水胶体从反应炉内移出并冷却固化,备用;
(2)涂覆水胶体,把水胶体放入涂胶机,涂胶温度控制在90-150℃,宽度根据离型纸宽度设定,水胶体层厚度约0.2mm-3mm。上下两层用不同离型力的离型膜覆盖,两层离型膜的剥离强度力值差为7克-20克,最后收卷作为压敏胶成品。
低致敏性性能评价:
本次临床试验,共入组216人,其中实施例1有72例,实施例2有72例,实施例3有72例。一般临床资料如下表:
观察项目 | 统计描述 | 实施例1 | 实施例2 | 实施例3 |
过敏史 | N(miss) | 72(0) | 72(0) | 72(0) |
无N(%) | 70(97.2%) | 70(97.2%) | 70(97.2%) | |
有N(%) | 2(2.8%) | 2(2.8%) | 2(2.8%) |
在受试者的皮肤伤口创面涂覆实施例中制得的水胶体,采用临床观察、记 录、检查等方式判断受试者7日后的过敏反应症状,评价水胶体致敏性性能,全身过敏性评价标准及实验结果如下:
全身过敏性评价标准
级数 | 过敏反应 |
0 | 过敏反应阴性 |
1 | 过敏反应弱阳性 |
2 | 过敏反应阳性 |
全身过敏性评价标准
从评价结果可以看出,原料中热塑性弹性体和松香树脂的含量越高,其抗敏性越强。
实施例4~6
一种过敏性低的高粘度水胶体配方,由下列重量份数的组分组成:
持粘性能测试:将样品裁切为2.5cm*7cm大小,将其纵向贴于两块紧靠的不锈钢板清洁表面上,要确保试样与钢板之间没有气泡,静止2h,将其垂直悬挂于实验架上,其中一块钢板固定于实验架上,另一块板下端悬挂1kg砝码,实验在23±2℃及65%±5%相对湿度条件下进行,记录砝码掉落时间,结果见下表。
实施例 | 持粘(h) |
4 | 28±4 |
5 | 24±6 |
6 | 19±5 |
从上表所列数据可以看出,产品持粘性与松香树脂、羧甲基纤维素钠和环烷油的加入量成正比,松香树脂和羧甲基纤维素钠的加入量增大时,水胶体黏附能力提高,环烷油也能够提高粘附性能。
本发明通过以上描述和实施例对实施方式及有益效果进行了说明,但本发明的权利要求范围不限于此。
Claims (8)
1.一种低过敏性的高粘度水胶体,其特征在于成分包括:热塑性弹性体比例为10-47%,松香树脂比例为30-58%,增稠剂比例为1-60%,优选地,使用羧甲基纤维素纳比例为1-38%,环烷油的比例为5-30%。
2.根据权利要求1所述的水胶体,其特征在于所述热塑性弹性体为苯乙烯橡胶类,优选的,热塑性弹性体可选用SIS,比例为20-43%。
3.根据权利要求1所述的水胶体,其特征在于所述松香树脂为松香甲酯、松香乙烯醇酯或甘油酯。
4.根据权利要求1所述的水胶体,其特征在于所述增稠剂为羧甲基纤维素钠、交联羧甲基纤维素钠、变性淀粉、环糊精、聚乙烯醇。
5.根据权利要求1所述的水胶体,其特征在于所述的水胶体初粘性>药典滚球法初粘性试验中的32号钢球。
6.根据权利要求1所述的水胶体,其特征在于,在水胶体中还加入功能成分,包括抗氧化剂、骨胶、聚异丁烯、羧甲基壳聚糖、色素、蜂蜜、甘油、藻酸盐、各种蛋白、发泡剂、沸石、远红外陶瓷粉、发泡剂和各种中药制剂中的一种或数种,共炼混合制成功能性水胶体。
7.根据权利要求1所述的水胶体制备方法,其特征是包括以下步骤:
1)将热塑性弹性体、环烷油加入反应炉内高温搅拌熔炼,熔炼温度控制在120℃-180℃,搅拌速度在20rpm-80rpm,时间为0.5-6小时;
2)依次添加增粘剂、增稠剂和权利要求中所述的功能性材料,继续搅拌0.5-2小时,搅拌总时间为1-8小时,期间温度控制在40℃-180℃左右;
3)水胶体从反应炉内移出并冷却固化,备用。
8.根据权利要求1所述的水胶体的使用方法,包括以下步骤:
1)涂覆水胶体:把水胶体放入涂胶机,涂胶温度控制在90-150℃,其宽度根据离型纸的宽度设定,水胶体层厚度约0.2mm-3mm;
2)覆盖离型膜:上下两层用不同离型力的离型膜覆盖,两层离型膜的剥离强度力值差为7克-20克;
3)收卷:收卷作为压敏胶成品。
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