CN112807484A - 一种具有缓释功能的高分子水凝胶及其制备方法 - Google Patents
一种具有缓释功能的高分子水凝胶及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种具有缓释功能的高分子水凝胶及其制备方法,所述水凝胶包括以下质量百分含量的各组分:0.01%‑15%的活性成分,0.01%‑15%离子抑制剂,0.01%‑1%交联剂,0.1%‑10%高分子树脂,10%‑35%溶剂,0.1%‑15%肤感调节剂,10%‑55%去离子水,0.1%‑3%外观调节剂,0.01‑1%的交联调节剂,0.01%‑1%防腐剂,0.01%‑5%透皮吸收促渗剂。本发明制得的高分子水凝胶具有良好的亲肤性和皮肤透过性,缓释药物时间长,与皮肤有良好的生物粘贴性,可反复揭帖,无残留胶体,特别是使用者在运动过程中使用,即使人体出汗仍然保持良好的粘贴性。
Description
技术领域
本发明涉及高分子水凝胶技术领域,具体涉及一种具有缓释功能的高分子水凝胶及其制备方法。
背景技术
由于人们越来越注重健康,经常运动,难免肌肉拉伤,或者运动前需要保护肌肉,但目前市面上的传统产品在运动过程中由于出汗,贴片易脱落,或者结合护具使用,使用感笨重。
目前绷带发展主要围绕基布改良,包括基布使用自粘胶带、弹力基布等等。然而在处理伤口后,绷带与皮肤伤口之间直接接触,伤口附近通常有溢出液存在,加上绷带通常透气性能差,容易发生细菌感染。给伤患带来巨大的痛苦,不利于伤口的愈合。而现有的使用热熔胶涂层的绷带无法具有实质的透皮给药的功能,且胶体不具有抗盐性,或者有些水凝胶绷带产品由于水凝胶易透布的弊端而设计的结构很复杂,使用感笨重,贴肤感不好,不轻薄,运动出汗易脱落。
发明内容
针对现有技术中的不足,本发明的目的是提供一种具有缓释功能的高分子水凝胶及其制备方法。
本发明的目的是通过以下技术方案实现的:
本发明提供了一种具有缓释功能的高分子水凝胶,包括以下质量百分含量的各组分:
0.01%-15%的活性药物成分,0.01%-15%离子抑制剂,0.01%-1%交联剂,0.1%-10%高分子树脂,10%-35%溶剂,0.1%-15%肤感调节剂,10%-55%去离子水,0.1%-3%外观调节剂,0.01-1%的交联调节剂,0.01%-1%防腐剂,0.01%-5%透皮吸收促渗剂。
优选地,所述高分子水凝胶,包括以下质量百分含量的各组分:
1%-10%的活性成分,3%-10%离子抑制剂,0.1%-0.5%交联剂,5%-10%高分子树脂,20%-35%溶剂,1%-5%肤感调节剂,30%-55%去离子水,0.1%-1%外观调节剂,0.1%-1%的交联调节剂,0.1-0.5%防腐剂,1%-5%透皮吸收促渗剂。
更优选地,所述高分子水凝胶,包括以下质量百分含量的各组分:
4%-6%的活性成分,5%离子抑制剂,0.1%-0.2%交联剂,8%-9.5%高分子树脂,30%-33%溶剂,0.1%肤感调节剂,40.9%-52.04%去离子水,0.05%-0.1%外观调节剂,0.2%的交联调节剂,0.1%防腐剂,0.5%透皮吸收促渗剂。
优选地,所述活性成分包括药物成分、中药粉末或提取液、氨基酸、植物提取物中的任一种或多种。例如所述药物成分可选自葡萄糖胺,辣椒提取物,樟脑,薄荷醇,水杨酸甲酯,利多卡因,盐酸利多卡因等镇痛作用成分,还可选自阿司匹林,安乃近,对乙酰氨基酚,吲哚美辛,吡罗昔康,酮咯酸,可的松、氢化可的松、***,甘草次酸,联苯乙酸,洛索洛芬等消炎镇痛作用成分;所述中药粉末或提取液可选自冰片,芦荟,山茶花,乳香树脂,山金车蒙大拿花,当归,决明子,金盏草花,紫锥菊,杜松果实等中药粉末或者提取液;所述氨基酸可选自甘氨酸、丝氨酸、L-色氨酸、精氨酸、鸟氨酸、5-羟色氨酸,L-茶氨酸、茶叶茶氨酸等;所述植物提取物可选自缬草提取物、西番莲提取物、柠檬香脂叶、黄春秋菊提取物、薰衣草提取物,洋甘菊提取物、香蜂草提取物、酸樱桃提取物、蒜提取物、留兰香提取物等助眠成分的植物提取物,还可选自冬青油,白芷油,当归油,肉桂油,桉叶油,薄荷油,龙脑油,广藿香油等具有提神醒脑的植物提取物。
优选地,所述离子抑制剂包括聚乙烯吡咯烷酮,聚乙烯醇的非离子型离子抑制剂中的至少一种。
优选地,所述交联剂为甘羟铝或氢氧化铝。
优选地,所述高分子树脂为聚丙烯酸,聚丙烯酸钠中的至少一种。
优选地,所述溶剂包括丙三醇,丙二醇,矿物油,聚氧乙烯脱水山梨醇单油酸酯中的至少一种。
优选地,所述肤感调节剂为高岭土,羧甲基纤维素纳中的至少一种;
所述外观调节剂为钛白粉。
更优选地,所述肤感调节剂为高岭土,其为吸油无机粉末,可以调节在运动过程中皮肤上分泌的油脂成分。
优选地,所述交联调节剂为酒石酸,柠檬酸,EDTA-2Na,EDTA-4Na,苹果酸,乳酸中的至少一种;
所述的防腐剂为苯扎氯铵,尼泊金甲酯,尼泊金丙酯,苯氧乙醇的至少一种;
所述的透皮吸收促渗剂为肉豆蔻酸异丙酯,二甲基亚砜,氮酮中的至少一种。
本发明还提供了一种具有缓释功能的高分子水凝胶的制备方法,包括以下步骤:
S1、将聚丙烯酸钠,交联剂,交联调节剂,外观调节剂,与溶剂常温下搅拌8-15分钟,分散均匀为A相;
S2、将活性药物成分加入溶剂中常温溶解完全为B相;
S3、将离子抑制剂,肤感调节剂,透皮吸收促渗剂,防腐剂常温下搅拌15-20分钟,形成混合液为C相;
S4、将B相与C相在均质乳化机中乳化,然后将乳化后的液体倒入真空搅拌釜中,再将A相混入其中,搅拌,即得具有缓释功能的高分子水凝胶。
优选地,步骤S4中,所述乳化的转速为4000r/min,乳化时间为10-15分钟;所述搅拌的速度为40-60r/min,搅拌时间为10-15分钟。
常规的胶体贴敷人体会因为人体分泌的汗液而发生粘性变差,而本发明制备的水凝胶由于加入了一定含量的离子抑制剂,可增强汗液条件下的黏附效果。
与现有技术相比,本发明具有如下的有益效果:
本发明制备的水凝胶是将聚丙烯酸钠以交联状态存在于亲水性基质中,所形成的高分子骨架包埋活性成分,胶体复配使用非离子型的水性离子抑制剂,提高胶体的耐盐性,该亲水性高分子水凝胶具有良好的亲肤性和皮肤透过性,缓释药物时间长,与皮肤有良好的生物粘贴性,可反复揭帖,无残留胶体,特别是使用者在运动过程中使用,即使人体出汗仍然保持良好的粘贴性。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明,但不以任何形式限制本发明。应当指出的是,对本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进。这些都属于本发明的保护范围。
实施例1
本实施例提供了一种具有缓释功能的高分子水凝胶,包括以下质量百分含量的各组分:4%利多卡因(活性成分),5%聚乙烯吡咯烷酮(离子抑制剂),0.1%甘羟铝(交联剂),5%聚丙烯酸钠(高分子树脂),聚丙烯酸3%(高分子树脂),24%的丙三醇(溶剂),5%丙二醇(溶剂),1%聚氧乙烯脱水山梨醇单油酸酯(溶剂),0.1%高岭土(肤感调节剂),0.05%钛白粉(外观调节剂),0.1%酒石酸(交联调节剂),0.1%EDTA-2Na(交联调节剂),0.1%苯氧乙醇(防腐剂),0.5%二甲基亚砜(透皮吸收促渗剂),51.95%去离子水。
所述高分子水凝胶的制备方法如下:
(1)将聚丙烯酸钠,甘羟铝,高岭土,EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相;
(2)将利多卡因加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相;
(3)将聚乙烯吡咯烷酮,钛白粉,二甲基亚砜,苯氧乙醇,在去离子水中常温下搅拌15-20分钟,形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟,转速为4000r/min.,然后将混合后的液体倒入真空搅拌釜中,再将A相混入其中,搅拌10-15分钟,搅拌速度为40-60r/min,形成包埋活性药物成分的水凝胶膏体。
实施例2
本实施例提供了一种具有缓释功能的高分子水凝胶,包括以下质量百分含量的各组分:5%薄荷醇(活性成分),5%聚乙烯吡咯烷酮(离子抑制剂),0.1%甘羟铝(交联剂),5.5%聚丙烯酸钠(高分子),3.5%聚丙烯酸(高分子),23%的甘油(溶剂),7%丙二醇(溶剂),1%聚氧乙烯脱水山梨醇单油酸酯(溶剂),0.1%羧甲基纤维素纳(肤感调节剂),0.1%钛白粉(外观调节剂),0.1%酒石酸(交联调节剂),0.1%EDTA-2Na,(交联调节剂)0.1%苯扎氯铵(防腐剂),0.5%肉豆蔻酸异丙酯(透皮吸收促渗剂),48.9%去离子水。
所述高分子水凝胶的制备方法如下:
(1)将聚丙烯酸钠,甘羟铝,羧甲基纤维素钠,EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相;
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相;
(3)将聚乙烯吡咯烷酮,钛白粉,肉蔻酸异丙酯,苯氧乙醇,在去离子水中常温下搅拌15-20分钟,形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟,转速为4000r/min.,然后将混合后的液体倒入真空搅拌釜中,再将A相混入其中,搅拌10-15分钟,搅拌速度为40-60r/min,形成包埋活性成分的水凝胶膏体。
实施例3
本实施例提供了一种具有缓释功能的高分子水凝胶,包括以下质量百分含量的各组分:5%薄荷醇(活性成分),5%聚乙烯吡咯烷酮(离子抑制剂),0.2%氢氧化铝(交联剂),3.5%聚丙烯酸钠(高分子),6%聚丙烯酸(高分子),25%的甘油(溶剂),7%丙二醇(溶剂),1%聚氧乙烯脱水山梨醇单油酸酯(溶剂),0.1%羧甲基纤维素纳(肤感调节剂),0.1%钛白粉(外观调节剂),0.1%酒石酸(交联调节剂),0.1%EDTA-2Na(交联调节剂),0.1%尼泊金甲酯(防腐剂),0.1%尼泊金丙酯(防腐剂),0.5%肉豆蔻酸异丙酯(透皮吸收促渗剂),46.2%去离子水。
所述高分子水凝胶的制备方法如下:
(1)将聚丙烯酸钠,氢氧化铝,羧甲基纤维素钠,EDTA-2Na,酒石酸与丙三醇常温下搅拌10分钟为A相;
(2)将薄荷醇加入丙二醇和聚氧乙烯脱水山梨醇单油酸酯中常温溶解完全为B相;
(3)将聚乙烯吡咯烷酮,钛白粉,肉蔻酸异丙酯,尼泊金甲酯,尼泊金丙酯,在去离子水中常温下搅拌15-20分钟,形成混合液为C相。
(4)将B相与C相在均质乳化机中乳化10-15分钟,转速为4000r/min.,然后将混合后的液体倒入真空搅拌釜中,再将A相混入其中,搅拌10-15分钟,搅拌速度为40-60r/min,形成包埋活性成分的水凝胶膏体。
实施例4
本发明提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮。
上述实施例1-4所制备的水凝胶具有良好的亲肤性和皮肤透过性,缓释药物时间长,与皮肤有良好的生物粘贴性,可反复揭帖,无残留胶体,特别是使用者在运动过程中使用,即使人体出汗仍然保持良好的粘贴性。
实施例5
本发明提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮,且聚乙烯醇含量为3%,去离子水含量为53.95%。
实施例6
本发明提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮,且聚乙烯醇含量为8%,去离子水含量为48.95%。
实施例7
本发明提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本实施例采用聚乙烯醇代替聚乙烯吡咯烷酮,且聚乙烯醇含量为10%,去离子水含量为46.95%。
对比例1
本对比例提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本对比例中不添加交联剂,去离子水含量为52.14%。
所述高分子水凝胶的制备方法与实施例1相同。
制得的胶体由于没有交联剂,交联过程发生过快或者过慢,胶体交联程度不均匀,无法进行涂布。
对比例2
本对比例提供了一种具有缓释功能的高分子水凝胶,其各组分组成与实施例1基本相同,不同之处仅在于:本对比例中不添加离子抑制剂,去离子水含量为56.95%。
所述高分子水凝胶的制备方法与实施例1相同。
效果验证:
将实施例1和对比例2制备的水凝胶膏体涂布在弹性布上,覆盖离型覆盖层,剪切,固化,得水凝胶膏贴。将制得的水凝胶膏贴进行效果测试,具体测试方法和结果如下:
分别将实施例1和对比例2的凝胶贴裁剪成30cm*2.5cm条状样品3片,分别在每片水凝胶膏贴表面均匀涂抹约2克人工汗液在25±2℃,60%RH的条件下预处理2小时,按照GB/T 2792-2014剥离力测试方法,测试结果如下表1所示:
表1
从上述测试结果来看,对比例2由于未加入离子抑制剂,在浸入人工汗液的条件下,黏附效果明显降低。
根据前述方法将实施例2-7凝胶贴裁剪成30cm*2.5cm条状样品3片,分别在每片水凝胶膏贴表面均匀涂抹约2克人工汗液在25±2℃,60%RH的条件下预处理2小时,按照GB/T2792-2014剥离力测试方法,测试结果(取3片样品的平均值)如下表2所示:
表2
上述的对实施例的描述是为便于该技术领域的普通技术人员能理解和使用发明。熟悉本领域技术的人员显然可以容易地对这些实施例做出各种修改,并把在此说明的一般原理应用到其他实施例中而不必经过创造性的劳动。因此,本发明不限于上述实施例,本领域技术人员根据本发明的揭示,不脱离本发明范畴所做出的改进和修改都应该在本发明的保护范围之内。
Claims (10)
1.一种具有缓释功能的高分子水凝胶,其特征在于,包括以下质量百分含量的各组分:
0.01%-15%的活性成分,0.01%-15%离子抑制剂,0.01%-1%交联剂,0.1%-10%高分子树脂,10%-35%溶剂,0.1%-15%肤感调节剂,10%-55%去离子水,0.1%-3%外观调节剂,0.01-1%的交联调节剂,0.01%-1%防腐剂,0.01%-5%透皮吸收促渗剂。
2.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述活性成分包括药物成分、中药粉末或提取液、氨基酸、植物提取物中的任一种或多种。
3.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述离子抑制剂包括聚乙烯吡咯烷酮,聚乙烯醇的非离子型离子抑制剂中的至少一种。
4.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述交联剂为甘羟铝或氢氧化铝。
5.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述高分子树脂为聚丙烯酸,聚丙烯酸钠中的至少一种。
6.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述溶剂包括丙三醇,丙二醇,矿物油,聚氧乙烯脱水山梨醇单油酸酯中的至少一种。
7.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述肤感调节剂为高岭土,羧甲基纤维素纳中的至少一种;
所述外观调节剂为钛白粉。
8.根据权利要求1所述的具有缓释功能的高分子水凝胶,其特征在于,所述交联调节剂为酒石酸,柠檬酸,EDTA-2Na,EDTA-4Na,苹果酸,乳酸中的至少一种;
所述的防腐剂为苯扎氯铵,尼泊金甲酯,尼泊金丙酯,苯氧乙醇的至少一种;
所述的透皮吸收促渗剂为肉豆蔻酸异丙酯,二甲基亚砜,氮酮中的至少一种。
9.一种根据权利要求1所述的具有缓释功能的高分子水凝胶的制备方法,其特征在于,包括以下步骤:
S1、将聚丙烯酸钠,交联剂,交联调节剂,外观调节剂,与部分溶剂常温下搅拌8-15分钟,分散均匀为A相;
S2、将活性药物成分加入部分溶剂中常温溶解完全为B相;
S3、将离子抑制剂,肤感调节剂,透皮吸收促渗剂,防腐剂常温下搅拌15-20分钟,形成混合液为C相;
S4、将B相与C相在均质乳化机中乳化.,然后将乳化后的液体倒入真空搅拌釜中,再将A相混入其中,搅拌,即得具有缓释功能的高分子水凝胶。
10.根据权利要求9所述的具有缓释功能的高分子水凝胶的制备方法,其特征在于,步骤S4中,所述乳化的转速为4000r/min,乳化时间为10-15分钟;所述搅拌的速度为40-60r/min,搅拌时间为10-15分钟。
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