CN106619491B - 一种药物缓释水凝胶及其制备方法 - Google Patents
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Abstract
本发明公开一种药物缓释水凝胶，包括如下重量百分比的原料：0.1～1％的药物分子、1～5％的促渗剂，0.2～2％的马来酸酐十四醇基丙磺酸钠、6～45％的溶剂、1～15％的丙烯酸钠树脂、0.01～1％的交联剂、1～15％的增粘剂、0.01～0.5％的催化剂以及余量水。本发明还公开了一种药物缓释水凝胶的制备方法，先将马来酸酐十四醇基丙磺酸钠与药物分子、溶剂和促渗剂共混，生成有表面活性的单体包裹药物后，将该单体包裹药物在由丙烯酸钠树脂、交联剂、增粘剂以及催化剂的水溶液构成的水凝胶基质中进行辐照聚合，即得该药物缓释水凝胶产品，该药物缓释水凝胶的缓释效果好，药物释放的稳定性有所提高。
Description
技术领域
本发明涉及高分子技术领域及药物缓释型技术领域，具体涉及的是一种药物缓释水凝胶及其制备方法。
背景技术
水凝胶是一类以水溶性高分子聚合物为基质骨架材料的交联聚合物，具有载药量大，保湿性强，与皮肤的相容性好，耐老化等特点，因此水凝胶可广泛应用在组织修复、人造器官、药物缓释及传感器等诸多领域。常用作药物缓释载体的水凝胶贴可以反复揭贴、随时终止给药；且保证剂量准确，血药浓度平衡无峰谷现象，可减少毒副作用；在工业生产中无有机溶媒污染，符合环保要求，从而成为当代药剂学研究的热门之一。
水凝胶的药物释放过程是一个动力学和热力学的复合过程，为了让水凝胶的释放作用更加稳定，通常加入粉料来延长产品的扩散通道，稳定药物释放的过程，例如日本药店贩售的水凝胶药剂就有规定加入高岭土用于稳定药物释放的过程。但是，现有的水凝胶仍存在缓释效果差、不稳定等问题，使得有效成分不能发挥应有的药效，因此，水凝胶的药物释放的稳定性问题仍有进一步探讨的空间。
发明内容
本发明的目的在于提供一种药物缓释水凝胶及其制备方法，制备的水凝胶缓释效果好，药物释放的稳定性有所提高。
为了达成上述目的，本发明的解决方案是：
一种药物缓释水凝胶，包括如下重量百分比的原料：
所述促渗剂为月桂氮酮或者二甲亚砜，所述交联剂为甘羟铝，所述增粘剂为聚乙烯吡咯烷酮，所述催化剂为酒石酸。
所述药物分子为吲哚美辛或者布洛芬。
所述丙烯酸钠树脂由日本昭和公司购买得到。
所述溶剂为乙醇和丙三醇的混合物，所述乙醇的重量百分用量为1～5％，所述丙三醇的重量百分用量为5～40％。
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)将0.2～2％的马来酸酐十四醇基丙磺酸钠、6～45％的溶剂、1～5％的促渗剂以及0.1～1％的药物分子混合均匀，形成单体包裹药物溶液；
(2)将0.01～0.5％的催化剂酒石酸溶于水中制备成酒石酸水溶液；
(3)向步骤(1)得到的所述单体包裹药物溶液中依次加入1～15％的丙烯酸钠树脂、0.01～1％的交联剂甘羟铝、1～15％的增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将所述水凝胶前驱物模压成型，在60Coγ射线下辐照后取出，所述60Coγ射线的辐照量为0.5-8kGy，即得该药物缓释水凝胶产品；步骤(1)～(3)中各组分的用量总和为100％。
步骤(1)中，所述溶剂为乙醇和丙三醇的混合物，所述乙醇的重量百分用量为1～5％，所述丙三醇的重量百分用量为5～40％。
马来酸酐十四醇基丙磺酸钠是经典的无皂乳液聚合中的反应性高分子乳化单体【Acta Polymerica,1998,29(12):4508-4515】，具有良好的乳化能力，在本发明的技术方案中，将其作为自乳化单体，先与药物分子、溶剂和促渗剂共混，生成有表面活性的单体包裹药物后，将该单体包裹药物在由丙烯酸钠树脂、交联剂甘羟铝、增粘剂聚乙烯吡咯烷酮以及酒石酸水溶液构成的水凝胶基质中进行辐照聚合，通过辐照使得马来酸酐十四醇基丙磺酸钠交联形成胶束粒子，从而获得稳定的胶束粒子包裹的缓释药物水凝胶，由此提高药物释放的稳定性。
附图说明
图1为本发明实施例一中制备得到的药物缓释水凝胶(A)与市售水凝胶巴布贴(B)的缓释效果对比图。
具体实施方式
为了进一步解释本发明的技术方案，下面通过具体实施例来对本发明进行详细阐述。
一种药物缓释水凝胶，包括如下重量百分比的原料：
所述促渗剂为月桂氮酮或者二甲亚砜，所述交联剂为甘羟铝，所述增粘剂为聚乙烯吡咯烷酮，所述催化剂为酒石酸。
所述药物分子为吲哚美辛或者布洛芬。
所述丙烯酸钠树脂由日本昭和公司购买得到。
所述溶剂为乙醇和丙三醇的混合物，所述乙醇的重量百分用量为1～5％，所述丙三醇的重量百分用量为5～40％。
一种药物缓释水凝胶的制备方法，包括以下步骤：
(1)将0.2～2％的马来酸酐十四醇基丙磺酸钠、6～45％的溶剂、1～5％的促渗剂以及0.1～1％的药物分子混合均匀，形成单体包裹药物溶液；
(2)将0.01～0.5％的催化剂酒石酸溶于水中制备成酒石酸水溶液；
(3)向步骤(1)得到的所述单体包裹药物溶液中依次加入1～15％的丙烯酸钠树脂、0.01～1％的交联剂甘羟铝、1～15％的增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将所述水凝胶前驱物模压成型，在60Coγ射线下辐照后取出，所述60Coγ射线的辐照量为0.5-8kGy，即得该药物缓释水凝胶产品；步骤(1)～(3)中各组分的用量总和为100％。
实施例一
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)按照配方比例，将0.5g马来酸酐十四醇基丙磺酸钠、3g乙醇、15g丙三醇、0.35g吲哚美辛以及2g促渗剂月桂氮酮混合均匀，形成单体包裹药物溶液；
(2)将0.1g催化剂酒石酸溶于64.03g水中制备成酒石酸水溶液；
(3)向步骤(1)得到的单体包裹药物溶液中依次加入10g丙烯酸钠树脂、0.02g交联剂甘羟铝、5g增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将水凝胶前驱物模压成片状，在60Coγ射线下辐照后取出，60Coγ射线的辐照量为4kGy，即得该药物缓释水凝胶产品。
为了更好地证明该药物缓释水凝胶的缓释效果，将该药物缓释水凝胶(A)与市售水凝胶巴布贴(B)进行了对比，两者的药物分子的含量相同，结果如图1所示，其中x轴为时间(h)，y轴为释放百分比(％)。结果表明：该药物缓释水凝胶产品的缓释效果和稳定性都较佳。
实施例二
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)按照配方比例，将0.8g马来酸酐十四醇基丙磺酸钠、3g乙醇、20g丙三醇、0.5g吲哚美辛以及2.5g促渗剂月桂氮酮混合均匀，形成单体包裹药物溶液；
(2)将0.1g催化剂酒石酸溶于55.08g水中制备成酒石酸水溶液；
(3)向步骤(1)得到的单体包裹药物溶液中依次加入10g丙烯酸钠树脂、0.02g交联剂甘羟铝、8g增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将水凝胶前驱物模压成片状，在60Coγ射线下辐照后取出，60Coγ射线的辐照量为0.5kGy，即得该药物缓释水凝胶产品。
实施例三
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)按照配方比例，将2g马来酸酐十四醇基丙磺酸钠、3g乙醇、10g丙三醇、0.5g吲哚美辛以及3g促渗剂二甲亚砜混合均匀，形成单体包裹药物溶液；
(2)将0.1g催化剂酒石酸溶于54.35g水中制备成酒石酸水溶液；
(3)向步骤(1)得到的单体包裹药物溶液中依次加入15g丙烯酸钠树脂、0.05g交联剂甘羟铝、12g增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将水凝胶前驱物模压成片状，在60Coγ射线下辐照后取出，60Coγ射线的辐照量为2kGy，即得该药物缓释水凝胶产品。
实施例四
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)按照配方比例，将1.5g马来酸酐十四醇基丙磺酸钠、5g乙醇、20g丙三醇、0.5g布洛芬以及2g促渗剂月桂氮酮混合均匀，形成单体包裹药物溶液；
(2)将0.1g催化剂酒石酸溶于50.7g水中制备成酒石酸水溶液；
(3)向步骤(1)得到的单体包裹药物溶液中依次加入15g丙烯酸钠树脂、0.2g交联剂甘羟铝、5g增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将水凝胶前驱物模压成片状，在60Coγ射线下辐照后取出，60Coγ射线的辐照量为6kGy，即得该药物缓释水凝胶产品。
实施例五
该药物缓释水凝胶的制备方法，包括以下步骤：
(1)按照配方比例，将1g马来酸酐十四醇基丙磺酸钠、3g乙醇、15g丙三醇、0.5g吲哚美辛以及4g促渗剂二甲亚砜混合均匀，形成单体包裹药物溶液；
(2)将0.4g催化剂酒石酸溶于54.3g水中制备成酒石酸水溶液；
(3)向步骤(1)得到的单体包裹药物溶液中依次加入12g丙烯酸钠树脂、0.8g交联剂甘羟铝、9g增粘剂聚乙烯吡咯烷酮以及步骤(2)得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
(4)将水凝胶前驱物模压成片状，在60Coγ射线下辐照后取出，60Coγ射线的辐照量为8kGy，即得该药物缓释水凝胶产品。
上述实施例和图式并非限定本发明的产品形态和式样，任何所属技术领域的普通技术人员对其所做的适当变化或修饰，皆应视为不脱离本发明的专利范畴。
Claims (2)
1.一种药物缓释水凝胶，其特征在于：包括如下重量百分比的原料：
药物分子 0.1~1%
促渗剂 1~5%
马来酸酐十四醇基丙磺酸钠 0.2~2%
溶剂 6~45%
丙烯酸钠树脂 1~15%
交联剂 0.01~1%
增粘剂 1~15%
催化剂 0.01~0.5%
余量为水；
所述促渗剂为月桂氮酮或者二甲亚砜，所述交联剂为甘羟铝，所述增粘剂为聚乙烯吡咯烷酮，所述催化剂为酒石酸，所述药物分子为吲哚美辛或者布洛芬，所述溶剂为乙醇和丙三醇的混合物；
所述药物缓释水凝胶的制备方法，包括以下步骤：
（1）将0.2~2%的马来酸酐十四醇基丙磺酸钠、6~45%的溶剂、1~5%的促渗剂以及0.1~1%的药物分子混合均匀，形成单体包裹药物溶液，所述促渗剂为月桂氮酮或者二甲亚砜；
（2）将0.01~0.5%的催化剂酒石酸溶于水中制备成酒石酸水溶液；
（3）向步骤（1）得到的所述单体包裹药物溶液中依次加入1~15%的丙烯酸钠树脂、0.01~1%的交联剂甘羟铝、1~15%的增粘剂聚乙烯吡咯烷酮以及步骤（2）得到的酒石酸水溶液，混合均匀，得到稠状的水凝胶前驱物；
（4）将所述水凝胶前驱物模压成型，在60Coγ射线下辐照后取出，所述60Coγ射线的辐照量为0.5-8kGy，即得该药物缓释水凝胶产品；步骤（1）~（3）中各组分的用量总和为100%。
2.根据权利要求1所述的一种药物缓释水凝胶的制备方法，其特征在于：所述乙醇的重量百分用量为1~5%，所述丙三醇的重量百分用量为5~40%。
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