CN110693856A - 一种含有微胶囊的缓释贴剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种含有微胶囊的缓释贴剂,所述贴剂自上而下包括底纸、储药胶层以及背衬材料三层结构,所述的储药胶层的成分按干燥后的重量份计包括:50份高分子基质、30‑60份微胶囊、15‑30份双氯酚酸钠以及5‑20份促渗透剂。本发明专利首次将微胶囊应用于压敏胶型双氯酚酸钠止痛贴剂的配方中,并成功制备出载药量高、稳定性好且不残胶的新型含微胶囊的止痛贴剂。
Description
技术领域
本发明属于经皮给药技术领域,具体涉及一种含有双氯酚酸钠的缓释贴剂及其制备方法。
背景技术
双氯酚酸钠是一种新型的且在临床上广泛应用的非甾体抗炎阵痛药,具备良好的解热阵痛作用,临床上可用于治疗类风湿关节炎、强直性关节炎、红斑狼疮、腰背痛、肩周炎及各类手术后引发的疼痛或各种原因引起的发热等疾病。
双氯酚酸钠常用的制剂类型主要包括三类:口服制剂、注射剂以及经皮给药制剂。其中,经皮给药制剂因具有使用方便、副作用小、血药浓度稳定以及疗效持续时间长等诸多优点而得到广泛研究。然而,双氯酚酸钠在水溶性及脂溶性高分子基质中的溶解度均很小,当载药量较大时(如超过10%),制成的贴剂在长期存放过程中易出现双氯酚酸钠结晶析出的现象,导致有效成分无法被人体皮肤吸收而显著降低了药品的疗效。
发明内容
综上所述,本发明的目的之一是提供一种含有微胶囊和双氯酚酸钠的载药量高、储存稳定性好,且具有良好镇痛效果的经皮给药贴剂。
本发明的另一个目的是提供制备上述止痛贴剂的方法。
一种含有微胶囊的缓释贴剂,所述贴剂自上而下包括底纸、储药胶层以及背衬材料三层结构。
其中,所述的储药胶层的成分按干燥后的重量份计包括:50份高分子基质、30-60份微胶囊、15-30份双氯酚酸钠以及5-20份促渗透剂。
其中,所述的高分子基质水性丙烯酸酯树脂、水性聚氨酯或两者的混合物。
其中,所述的微胶囊是一种具有核-臂-端结构且内含高粘性基团的囊状嵌段聚合物。
其中,所述的促渗透剂是薄荷油、甘油、氮酮、松节油、冰片以及桉油中的一种或多种。
一种如上所述的含有微胶囊的缓释贴剂的制备方法,其具体的制备方法是:按比例将高分子基质、微胶囊、双氯酚酸钠以及促渗透剂混合均匀后,涂布在底纸上,经70~110℃烘箱干燥后,与背衬材料进行复合,最后经模切获得特定尺寸的贴剂,即得。
本发明所述的微胶囊是具有“核-外臂-壳”三层结构的微米软性乳胶粒(粒径控制在20~40μm),其中心是由疏水性单体聚合并交联而形成的“核”。在核的外表面接枝大量含有强极性基团高分子柔性亲水性长链,从而形成“外臂”。在每个外臂的末端连接着一定分子量的疏水性链段,且这些疏水性末端通过范德华力相互吸引,形成半开放的“壳”,起到保护内部外臂上的极性基团的作用。在外界压力作用下,由各疏水链段组成的壳,将会打开,暴露出内部含有大量强极性基团的柔性外臂,并与界面形成粘贴作用,而当外力撤去后,上述含有大量强极性基团的外臂将收缩回“壳”内,从而将极性基团保护起来。
本发明具有如下有益效果:
本发明专利首次将微胶囊应用于压敏胶型双氯酚酸钠止痛贴剂的配方中,并成功制备出载药量高、稳定性好且不残胶的新型含微胶囊的止痛贴剂。在本发明专利中,微胶囊主要提供以下两方面的有益效果:
其一,微胶囊的核和壳是疏水的,而外臂则是亲水的,即具有两亲性,这一特点使其成为双氯酚酸钠的高效载体。在搅拌作用下,双氯酚酸钠通过扩散进入微胶囊内部,并与微胶囊中的非极性链段和极性链段分别发生物理相互作用,使其能够稳定溶解在微胶囊中,从而获得长期存储稳定性,而不会发生解析析出现象。本发明专利中,储药胶层中的载药量约为10%~20%,载药量高,且稳定性好。在使用时,在压力作用下,微胶囊的壳会打开,使得其内部的活性成分与皮肤直接接触,进而通过扩散进入皮肤而发挥疗效。
其二,微胶囊的外臂上的大量粘性基团同时也是本发明专利中的止痛贴剂的粘性来源。在搅拌作用下,微胶囊均匀地分散在高分子基质中,因此,从微观上看有微胶囊的区域是有粘性的,没有微胶囊的地方是没有粘性的。正是利用这种“粘-不粘交替出现”的微观结构,赋予了本止痛贴剂优异的可移性,使其具有在揭离时不留残胶的优异特性。
具体实施方式
下面结合一些具体实施方式对本发明做进一步描述。具体实施例为进一步详细说明本发明,非限定本发明的保护范围。
微胶囊聚合物的供应商为:中山荣思东数码科技有限公司
实施例1
(1)储药胶层成分配比,以干燥后的重量份计:
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性丙烯酸酯乳液,搅拌均匀后,继续加入微胶囊乳液和薄荷油,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单PE淋膜单面涂硅的离型纸上,经70~110℃烘箱干燥后,与医用无纺布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
实施例2
(1)储药胶层成分配比,以干燥后的重量份计:
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性丙烯酸酯乳液,搅拌均匀后,继续加入微胶囊乳液和薄荷油,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单PE淋膜单面涂硅的离型纸上,经70~110℃烘箱干燥后,与医用无纺布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
实施例3
(1)储药胶层成分配比,以干燥后的重量份计:
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性丙烯酸酯乳液,搅拌均匀后,继续加入微胶囊乳液和薄荷油,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单PE淋膜单面涂硅的离型纸上,经70~110℃烘箱干燥后,与医用无纺布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
实施例4
(1)储药胶层成分配比,以干燥后的重量份计:
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性聚氨酯乳液,搅拌均匀后,继续加入微胶囊乳液和氮酮,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单面涂硅的离型膜上,经70~110℃烘箱干燥后,与医用棉布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
实施例5
(1)储药胶层成分配比,以干燥后的重量份计:
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性聚氨酯乳液,搅拌均匀后,继续加入微胶囊乳液和氮酮,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单面涂硅的离型膜上,经70~110℃烘箱干燥后,与医用棉布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
对比例1
(1)储药胶层成分配比,以干燥后的重量份计:
水性丙烯酸酯 50份
双氯芬酸钠 10份
薄荷油 5份
(2)止痛贴剂的制备方法:
首先,将双氯酚酸钠溶于乙醇,然后将其加入水性丙烯酸酯乳液,搅拌均匀后,继续薄荷油,充分搅拌直至混合均匀。然后,将混合均匀后的胶药混合液涂布在单PE淋膜单面涂硅的离型纸上,经70~110℃烘箱干燥后,与医用无纺布进行复合,制成半成品。最后,将上述半成品,模切成特定的规格尺寸,即得相应的止痛贴剂。
实施例和对比例的止痛贴剂进行以下测试,测试结果如表1所示:
载药量:
采用水、乙醇等有机溶剂将储药胶层的双氯芬酸纳溶解出来,再将双氯芬酸纳过滤分离提取出来,再用气相色谱仪和气相质谱仪进行定性和定量检测。
载药量的计算公式为:LE(%)=We/Wm×100%;式中LE表示储药胶层中药物的载药量百分数;We表示在储药胶层中双氯芬酸纳的药量;Wm表示储药胶层的总重量。
双氯芬酸钠结晶析出情况:采用偏光显微镜观察贴剂中双氯芬酸钠结晶析出情况,当有结晶析出时,会观察到十字消光现象。
揭离时残胶情况:将贴剂贴在人体皮肤上保持12h,将贴剂揭开,观察皮肤上是否有胶水残留。
12小时药物经皮释放量:药物经皮释放量是通过Franz垂直扩散池测定。
表1
以上所述仅为本发明的实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (6)
1.一种含有微胶囊的缓释贴剂,其特征在于:所述贴剂自上而下包括底纸、储药胶层以及背衬材料三层结构。
2.如权利要求1所述的含有微胶囊的缓释贴剂,其特征在于:所述的储药胶层的成分按干燥后的重量份计包括:50份高分子基质、30-60份微胶囊、15-30份双氯酚酸钠以及5-20份促渗透剂。
3.如权利要求2所述的含有微胶囊的缓释贴剂,其特征在于:所述的高分子基质水性丙烯酸酯树脂、水性聚氨酯或两者的混合物。
4.如权利要求3所述的含有微胶囊的缓释贴剂,其特征在于:所述的微胶囊是一种具有核-臂-端结构且内含高粘性基团的囊状嵌段聚合物。
5.如权利要求3所述的含有微胶囊的缓释贴剂,其特征在于所述的促渗透剂是薄荷油、甘油、氮酮、松节油、冰片以及桉油中的一种或多种。
6.根据权利要求书1-5任一项所述的含有微胶囊的缓释贴剂的制备方法,其特征在于,其具体的制备方法是:按比例将高分子基质、微胶囊、双氯酚酸钠以及促渗透剂混合均匀后,涂布在底纸上,经70~110℃烘箱干燥后,与背衬材料进行复合,最后经模切获得特定尺寸的贴剂,即得。
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CN101362067A (zh) * | 2007-08-06 | 2009-02-11 | 天津科技大学 | 一种微胶囊制备方法 |
CN104473904A (zh) * | 2014-11-10 | 2015-04-01 | 苏州蔻美新材料有限公司 | 缓释微胶囊及其应用 |
CN105708823A (zh) * | 2016-04-08 | 2016-06-29 | 中国药科大学 | 一种长效双氯芬酸类透皮贴剂及其制备工艺 |
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CN101362067A (zh) * | 2007-08-06 | 2009-02-11 | 天津科技大学 | 一种微胶囊制备方法 |
CN104473904A (zh) * | 2014-11-10 | 2015-04-01 | 苏州蔻美新材料有限公司 | 缓释微胶囊及其应用 |
CN105708823A (zh) * | 2016-04-08 | 2016-06-29 | 中国药科大学 | 一种长效双氯芬酸类透皮贴剂及其制备工艺 |
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