CN107041966A - 溶剂挥发成形水凝胶基质的组成配方及其制备方法 - Google Patents
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Abstract
本发明涉及溶剂挥发成形水凝胶基质的组成配方及其制备方法。具体而言,本发明提供一种水凝胶敷料基质,该基质以一配方制成,该配方包括聚甲基丙烯酸2‑羟基乙基酯,塑化剂,表面活性剂,水,以及乙醇,其中该聚甲基丙烯酸2‑羟基乙基酯:该塑化剂:该表面活性剂:该水:该乙醇的比例为8‑20(W/V%):1‑5(W/V%):0.1‑1(W/V%):70‑95(V/V%):5‑30(V/V%)。本发明还提供一种水凝胶敷料基质的制备方法。本发明的水凝胶状基质可涂布于体表,藉由体表温度加速溶媒挥发后快速形成密合的保护性薄膜,可应用于医疗及非医疗用途的可搭载生物活性成分的基剂。
Description
技术领域
本发明涉及一种以溶媒挥发快速塑形,可完整密合于物体表面的保护性水凝胶薄膜,尤其是一种溶剂挥发成形水凝胶基质的组成配方及其制备方法。
背景技术
凝胶是一种三度空间的聚合物网络,其吸收液体而形成安定,且具有非零切变模数的组成物。当被凝胶吸收的液体为水时,特称为水凝胶,其在生物医学应用上有广泛利用的机会。例如,美国专利号3,063,685、3,963,685和4,272,518揭露水凝胶作为软式隐形眼镜,其亦可在有和无加入可自凝胶基质释出的药物以帮助伤口愈合的过程的情况下,用作为烧伤和伤口包扎用品。
此外,于美国专利号5,292,515中,揭示一种制备适合于哺乳动物皮下植入的亲水性储囊药物输送装置的方法,其将水凝胶作为持续释放生物活性物质的装置,以水凝胶植入物的水含量来控制药物释出速率。前述应用中,水凝胶为不具有可辨识的规则的内部结构的不定形物质团块的一种疏松形态。由于相对于水必须通过而被吸收的表面积而言,疏松的水凝胶具有大的内部体积,因此其膨胀速率缓慢。此外,实际应用上,溶于或悬浮于被吸收的水中物质将扩散出凝胶,而其速率决定于其必须行进至凝胶外表面的距离,若各粒子足够小的情况时,分散于粒子中的物质可以用相近的时间扩散至表面并且释出。
而美国专利申请公开号2004/0086548A1号中,揭示自水凝胶颗粒生成的外形保持性凝聚团块及其生成方法,其膨体水凝胶的外形保持性与颗粒凝胶的物质释放控制,该生成方法包含制备在水中或其他极性液体中凝胶颗粒的悬浮液、浓缩该悬浮液直到该等颗粒凝结成,并且藉由非共价键物理力(包括不限于厌水性/亲水性交互作用及氢键)保持结合的外形保持性凝聚团块。此外,美国专利申请公开号US 2005/0118270A1号揭示在原位生成一种外形保持性凝聚团块的方法以及完成敷料生成的方式,其藉由导入胶质颗粒分散于极性液体(较佳为水)的悬浮液到一接收介质内。
发明内容
本发明揭露一种水凝胶敷料基质的配方与制备方法,其利用两性聚合物制成一种黏着具流动性的水凝胶状基质,此水凝胶状基质可涂布于体表,并藉由体表温度加速溶媒挥发后快速形成密合的保护性薄膜,可应用于医疗及非医疗用途的可搭载生物活性成分的基剂。
依据前述,一种水凝胶敷料基质的制备方法,包括:将聚甲基丙烯酸2-羟基乙基酯溶解于乙醇中,得到一聚甲基丙烯酸2-羟基乙基酯乙醇溶液;于该聚甲基丙烯酸2-羟基乙基酯乙醇溶液中加入水、表面活性剂和塑化剂,得到一聚甲基丙烯酸2-羟基乙基酯乙醇水溶液;移除该聚甲基丙烯酸2-羟基乙基酯乙醇水溶液中的乙醇,得到一移除了乙醇的聚甲基丙烯酸2-羟基乙基酯水溶液;以及于该移除了乙醇的聚甲基丙烯酸2-羟基乙基酯水溶液中加入特定量的乙醇,得到一黏稠的流动性水凝胶产物。
在本发明一个实施例中,该水凝胶敷料基质中,聚甲基丙烯酸2-羟基乙基酯:塑化剂:表面活性剂:水:乙醇的比例为8-20(W/V%):1-5(W/V%):0.1-1(W/V%):70-95(V/V%):5-30(V/V%)。
故而,关于本发明的优点与精神可以藉由以下发明详述及所附图式得到进一步的了解。
附图说明
图1为本发明的水凝胶敷料基质的制备方法实施例的流程示意图。
具体实施方式
以下将参照所附图式说明本发明的实施形态来叙述本发明。在图式中,相同的组件符号表示相同的组件,并且为求清楚说明,组件的大小或厚度可能夸大显示。
本发明所使用的聚甲基丙烯酸2-羟基乙基酯(pHEMA,Poly(2-hydroxyethyl methacrylate)),意指包括甲基丙烯酸2-羟基乙基酯重复单元的聚合物,其可具有25,000道尔顿至100,000道尔顿的分子量,多分散性(polydispersity)则可介于2至3.8。另外,本发明可使用不含分枝聚合物链与凝胶颗粒的pHEMA,例如低于约0.1重量百分比(W/V%)凝胶颗粒与/或分枝聚合物链,但不以此为限。
本发明以下使用的单位,将明确标示为重量百分组成(W/V%)或是体积百分组成(V/V%),因此于下列段落中,不同的单位表示将会出现于不同或相同段落中。
本发明以下所称的表面活性剂,主要包括非离子型表面活性剂,可以是亲水性的或亲油性的或是复合(两性)的,目的使本发明各配方组成完整相容。举例但不限地,例如使用失水山梨醇脂肪酸酯(Span)和其环氧乙烷加成物(Tween)的非离子型表面活性剂,其HLB值(Hydrophilic-LipophilicBalance)介于1.8至16.7,举例但不限地,例如较佳HLB值介于3.7至10.5。相较于离子型表面活性剂,非离子型表面活性剂具有较佳的配方稳定性、制定灵活性与兼容性。
本发明以下所称的塑化剂,是能够使材料柔软或液化的添加剂,使高分子材料的分子间产生润滑,减少高分子材料的硬度,目的使该水凝胶基质具液体流动性与可塑性,及溶媒挥发塑形后,水凝胶薄膜柔软不易受外力作用而破损。举例但不限地,例如柠檬酸三乙酯(triethyl citrate)、聚乙二醇(PEG)或甘油(Glycerin)等。在本发明中专指较安全的塑化剂种类,具有生物可降解性,也不容易造成生物的化学反应,举例来说:乙酰单酸甘油乙酯(Acetylated monoglyceride),可用作食品添加剂。而环己烷-1,2-二羧酸二异壬酯(1,2-Cyclohexane dicarboxylic acid diisononyl ester)(BASF的注册商标为DINCH),可用作食品包装、医疗器材及儿童玩具,此塑化剂和包括PVC在内的大部份聚合物相容。可用作食品包装、医疗器材、药物控释、化妆品及玩具的柠檬酸酯类(Alkyl citrates),如:柠檬酸三乙酯(Triethylcitrate,TEC)、柠檬酸乙酰基三乙酯(Acetyl triethyl citrate,ATEC)、柠檬酸三丁酯(Tributyl citrate,TBC)、柠檬酸乙酰基三丁酯(Acetyltributyl citrate,ATBC)、柠檬酸三辛酯(Trioctyl citrate,TOC)、柠檬酸乙酰基三辛酯(Acetyl trioctyl citrate,ATOC)、柠檬酸三己酯(Trihexylcitrate,THC)、柠檬酸乙酰基三己酯(Acetyl trihexyl citrate,ATHC)、丁酰柠檬酸三正己酯(Trihexyl o-butyryl citrate,BTHC)、柠檬酸三甲酯(Trimethyl citrate,TMC)。
图1为本发明水凝胶敷料基质的制备方法实施例的流程示意图。请参照图1步骤10:准备pHEMA的乙醇溶液(聚甲基丙烯酸2-羟基乙基酯乙醇溶液)。将两性聚合物,例如pHEMA溶解于适当的溶剂中,即在pHEMA的溶解度领域内,适合的溶剂具有于下列范围的溶解度参数:δD约介于13至20,δP约介于5至18,与δH约介于10至25,最佳者为:在三度空间的溶解度空间中,溶剂与聚合物间的距离不应超越下列数值:δD约介于5至10,δP约介于4至12,δH约介于6至10。于本实施例中,将pHEMA溶解于乙醇中,其较佳的重量百分比(W/V%)为10-20%。其次,步骤12:于pHEMA的乙醇溶液(聚甲基丙烯酸2-羟基乙基酯乙醇溶液)中加入表面活性剂、塑化剂和水并混合得到聚甲基丙烯酸2-羟基乙基酯乙醇水溶液。于本实施例中,表面活性剂可选用非离子型表面活性剂,其用量约为0.25%(W/V%);塑化剂的用量约为2%(W/V%);以及适量的水,例如40毫升。
接着,请参照图1步骤14:移除混合溶液中的乙醇。就常温常压(25℃,1大气压)的环境下乙醇的低蒸气压特性来说,静置包括pHEMA、乙醇、表面活性剂、塑化剂和水的混合溶液于常温常压时,混合溶液中的乙醇是可以挥发掉的。但本发明中,辅助同时使用抽气装置、32℃加热恒温装置与自动搅拌装置以加速移除混合溶液中的乙醇,以求混合溶液中的乙醇完全挥发来得到。当混合溶液中开始有凝结块状物体,此即pHEMA、表面活性剂、塑化剂的混合固体物,即是已将乙醇完全挥发。之后,步骤16:加入特定量的乙醇至包括pHEMA、表面活性剂、塑化剂和水的上述混合溶液中,使其成为具有流动性的均质黏稠液体产物(水凝胶产物)。于本实施例中,步骤16加入的乙醇和步骤14完成后所得的混合溶液(聚甲基丙烯酸2-羟基乙基酯水溶液)的体积比约为5至30(V/V%),较佳的体积比为8至25(V/V%)。
继续如图1步骤18:将步骤16所得的均质黏稠液体产物经过杀菌处理后分封得到水凝胶敷料的基质,以完成本发明。
本发明如前所述之一种水凝胶敷料基质的制备方法,包括将聚甲基丙烯酸2-羟基乙基酯溶解于乙醇中得到一聚甲基丙烯酸2-羟基乙基酯乙醇溶液,再于其中加入水、表面活性剂和塑化剂,得到一聚甲基丙烯酸2-羟基乙基酯乙醇水溶液,之后让乙醇水溶液中的乙醇挥发掉得到聚甲基丙烯酸2-羟基乙基酯水溶液,再将一定量的乙醇加入水溶液中,搅拌混合后得到一均质黏稠的流动性水凝胶产物。
本发明的申请专利范围;凡其它未脱离本发明所揭示的精神下所完成的等效改变或修饰,均应包含在下述的申请专利范围内。
Claims (7)
1.一种水凝胶敷料基质,其特征在于,该基质以一配方制成,该配方包括聚甲基丙烯酸2-羟基乙基酯,塑化剂,表面活性剂,水,以及乙醇,其中该聚甲基丙烯酸2-羟基乙基酯:该塑化剂:该表面活性剂:该水:该乙醇的比例为8-20(W/V%):1-5(W/V%):0.1-1(W/V%):70-95(V/V%):5-30(V/V%)。
2.一种水凝胶敷料基质的制备方法,其特征在于,该方法包括:
将聚甲基丙烯酸2-羟基乙基酯溶解于乙醇中,得到一聚甲基丙烯酸2-羟基乙基酯乙醇溶液;
于该聚甲基丙烯酸2-羟基乙基酯乙醇溶液中加入水、表面活性剂和塑化剂,以得到一聚甲基丙烯酸2-羟基乙基酯乙醇水溶液;
移除该聚甲基丙烯酸2-羟基乙基酯乙醇水溶液中的乙醇,得到一移除了乙醇的聚甲基丙烯酸2-羟基乙基酯水溶液;以及
于该移除了乙醇的聚甲基丙烯酸2-羟基乙基酯水溶液中加入乙醇,搅拌混合后得到一均质黏稠的流动性水凝胶产物。
3.如权利要求2所述的水凝胶敷料基质的制备方法,其特征在于,该聚甲基丙烯酸2-羟基乙基酯乙醇溶液中,聚甲基丙烯酸2-羟基乙基酯的重量百分比为8%到20%。
4.如权利要求2所述的水凝胶敷料基质的制备方法,其特征在于,移除该聚甲基丙烯酸2-羟基乙基酯乙醇水溶液中的乙醇的步骤包括同时使用抽气装置,32℃加热恒温装置与自动搅拌装置以移除该乙醇。
5.如权利要求2所述的水凝胶敷料基质的制备方法,其特征在于,于该移除了乙醇的聚甲基丙烯酸2-羟基乙基酯水溶液中加入乙醇的步骤中,加入的乙醇和该聚甲基丙烯酸2-羟基乙基酯水溶液的体积比为从8%到25%。
6.如权利要求2所述的水凝胶敷料基质的制备方法,其特征在于,该表面活性剂是选自失水山梨醇脂肪酸酯及其环氧乙烷加成物(Tween)的非离子性表面活性剂。
7.如权利要求2所述的水凝胶敷料基质的制备方法,其特征在于,该塑化剂选自柠檬酸三乙酯、聚乙二醇或其组合。
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