CN106943382B - 一种基于静电纺丝的压敏胶贴剂及其制备方法 - Google Patents
一种基于静电纺丝的压敏胶贴剂及其制备方法 Download PDFInfo
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- CN106943382B CN106943382B CN201710149985.8A CN201710149985A CN106943382B CN 106943382 B CN106943382 B CN 106943382B CN 201710149985 A CN201710149985 A CN 201710149985A CN 106943382 B CN106943382 B CN 106943382B
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- sensitive adhesive
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Images
Classifications
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- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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Abstract
本发明提供一种基于静电纺丝的压敏胶贴剂及其制备方法，属于外用贴剂技术领域。本发明利用静电纺丝技术，形成两种分别含有亲脂性药物和亲水性药物的纳米纤维丝，为不同药物提供通向皮肤的释放通道，其中，苯乙烯系压敏胶基质所形成的纳米纤维具有压敏粘结性能，局部相互粘连，并和亲水性药物释放基质所形成的纤维构成互穿网络结构，能有效地将体系粘附于皮肤表面。其益处：首先，通过静电纺丝技术制备具有双亲性含药纳米纤维基质能够避免两相间不相容的问题；其次，亲脂性药物和亲水性药物能够分别在各自的纳米纤维基质中独立地存储并释放，药物利用率高；另外，利用静电纺丝制备的双亲性含药纳米纤维基质孔隙率高，透气性好。
Description
技术领域
本发明属于外用贴剂技术领域，涉及一种基于静电纺丝的压敏胶贴剂及其制备方法。
背景技术
外用贴剂通过皮肤表面给药，使药物以近恒定速率通过皮肤进入体循环，产生全身或局部治疗作用。它能避免口服带来的不适和肝脏首过效应；能克服因吸收过快产生血药浓度过高而引起的不良反应；给药灵活、平稳、可控，不受消化道内pH值、食物等因素的影响。它主要由基质和药物两部分组成，药物分散在基质中，基质的作用是：一、作为药物的物资载体；二、为药物向皮肤表面输送提供通道；三、将给药系统有效粘附于皮肤表面。
在药物贴剂领域，有黑膏药类、橡胶膏、水凝胶、压敏胶等不同种类的基质，其中压敏胶基质具有使用方便、载药量高、可重复使用等诸多优势而备受关注，其典型代表是以苯乙烯-丁二烯-苯乙烯嵌段共聚物(SBS)、苯乙烯-异戊二烯-苯乙烯嵌段共聚物(SIS)和它们的氢化改良型嵌段共聚物(SEBS、SEPS)为骨架的亲脂性压敏胶和以丙烯酸酯为骨架的亲水性压敏胶，他们分别适用于亲脂性药物和亲水性药物，二者相比，后者的粘附性较差。在很多情况下，需要输送亲水性药物，或者需要亲水性药物和亲脂性药物同时输送，这在中医药领域较为常见。另外，发展高透气外用贴剂极为重要，能够有效促进皮肤呼吸，避免引起皮肤过敏。
发明内容
本发明的目的就是基于静电纺丝技术提供一种透气性良好的能满足不同药物经皮给药要求的压敏胶贴剂及其制备方法。
本发明的技术方案为：
一种基于静电纺丝的压敏胶贴剂，所述的压敏胶贴剂的主体组成包括苯乙烯系压敏胶纤维丝和释放亲水性药物的纤维丝，所述的苯乙烯系压敏胶纤维丝包括苯乙烯系热塑性弹性体、亲脂性药物、增粘剂等物质，所述的释放亲水性药物的纤维丝包括亲水性药物释放基质、亲水性药物、透皮促渗剂、抗氧剂等物质；
所述的苯乙烯系压敏胶纤维丝中各组分的重量份数为：
所述的释放亲水性药物的纤维丝中各组分的重量份数为：
所述苯乙烯系热塑弹性体为SBS、SIS、SEBS、SEPS中的一种或几种。
所述的增粘剂选自石油树脂、萜烯树脂、松香或其组合物。
所述的透皮促渗剂为乙醇、丙二醇或其组合物。
所述亲脂性药物为能够满足透皮给药要求的亲脂性单一组分药物或多组分药物的复配物。
所述亲水性基质为聚环氧乙烷、水性丙烯酸脂、水性聚氨酯、聚乙二醇、聚乙烯醇、聚丙烯酸钠、羧甲纤维素钠、明胶、甘油、微粉硅胶、多糖或其组合物。
所述亲水性药物为能够满足透皮给药要求的亲水性单一组分药物或多组分药物的复配物。
所述抗氧剂为N,N-二丁基氨基二硫代甲酸锌、橡胶促进剂或其组合物。
制备上述压敏胶贴剂的方法，本发明利用静电纺丝技术，将苯乙烯系压敏胶基质/亲脂性药物/透皮促渗剂/抗氧剂的纺丝溶液和亲水性药物释放基质/亲水性药物/透皮促渗剂/抗氧剂的纺丝溶液同时置于静电纺丝设备上，采用多针纺丝，形成两种分别含有亲脂性药物和亲水性药物的纳米纤维丝，为不同的药物提供通向皮肤的释放通道，同时，两种纤维丝能够相互贯穿，其中苯乙烯系压敏胶基质所形成的纳米纤维具有压敏粘结性能，局部相互粘连，和亲水性药物释放基质所形成的纤维构成互穿网络结构，能有效地将体系粘附于皮肤表面。上述方法还可适用于只有亲脂性药物或亲水性药物的情况，苯乙烯系压敏胶基质所形成的纳米纤维为体系提供压敏粘结的作用。具体包括以下步骤：
(1)将20～180重量份数苯乙烯系热塑弹性体、20～180重量份数增粘剂、5～75重量份数透皮促渗剂、5～150重量份数亲脂性药物及1～5重量份数抗氧剂，在混合溶剂A中充分溶解，制备固体浓度为5～35wt％的纺丝溶液，其中苯乙烯系热塑性弹性体与增粘剂的比例为9:1～1:9。
(2)将80～150重量份数亲水性基质、5～150重量份数亲水性药物、5～65重量份数透皮促渗剂及1～5重量份数抗氧剂，在混合溶剂B中充分溶解，制备固体浓度为5～35wt％的纺丝溶液。
(3)将两种纺丝溶液分别装入不同数量的注射器中，置于静电纺丝设备上进行静电纺丝，所述的装有压敏胶溶液的注射器数量与装有亲水药物溶液的注射器数量之比为6:1～1:6，采用平板收集或转鼓收集的方式收集纤维，接收平板或转鼓的表面贴有背衬材料，接收厚度为100±20μm～400±20μm，收集之后加盖衬材料，既得外用贴剂。所述的静电纺丝参数为：电压10～25kv，纺丝速度0.3～2.0ml/h，接收距离8～25cm,相对湿度为20～50％。
所述的混合溶剂A为甲苯、己烷、四氢呋喃、N,N-二甲基甲酰胺、环己烷、汽油、醋酸乙烯酯、油脂中的一种或几种组成；所述的混合溶剂B为四氢呋喃、N,N-二甲基甲酰胺、水、乙醇、乙酸、甲酸、醋酸乙烯酯中的一种或几种组成。所述的背衬材料为棉布、无纺布或纸；所述盖衬材料为防粘纸、塑料薄膜、铝箔-聚乙烯复合膜或硬质纱布。
本发明的效果和益处为：本发明克服了以往外用贴剂透气性较差和只能释放亲水或亲酯性的单一类药物的缺点，成功制备出一种透气性好的双亲外用贴剂。首先，通过静电纺丝技术制备具有双亲性含药纳米纤维基质能够避免两相间不相容的问题；其次，亲脂性药物和亲水性药物能够分别在各自的纳米纤维中独立地存储并释放，药物利用率高；另外，利用静电纺丝制备的双亲性含药纳米纤维基质孔隙率高，透气性好。
附图说明
图1为载药的SIS压敏胶纤维膜的扫描电镜图。
图2为聚环氧乙烷纤维膜的扫描电镜图。
图3为载药聚环氧乙烷纤维膜的扫描电镜图。
图4为载药聚环氧乙烷纤维/载药SIS压敏胶纤维复合膜的扫描电镜图。
图5为载药聚环氧乙烷纤维/载药SBS压敏胶纤维复合膜的扫描电镜图。
图6为载药聚乙烯醇：SEBS压敏胶纤维复合纤维膜的扫描电镜图。
图7为载药聚乙烯醇：SEPS压敏胶纤维复合纤维膜的扫描电镜图。
图8为载药多糖：SEPS压敏胶纤维复合纤维膜的扫描电镜图。
图9为载药多糖：SBS压敏胶纤维复合纤维膜的扫描电镜图。
图10为实例一、实例四中齐墩果酸药物释放曲线。
图11为实例三、实例四中栀子苷药物释放曲线。
具体实施方式
以下根据具体实施方式对本发明做进一步说明。
实施例1
(1)将80重量份数SIS热塑弹性体、80重量份数石油树脂、10重量份数丙二醇、50重量份数齐墩果酸及2重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷和汽油的混合溶剂(其中四氢呋喃与环己烷以及汽油三者的质量比为2:1:1)中充分溶解，制备固体浓度为16wt％的纺丝溶液。
(2)将上述纺丝溶液装入注射器，置于静电纺丝设备上进行纺丝，即得载药SIS热熔压敏胶纤维膜，其结构如附图1所示。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm，收集之后加盖衬材料，既得外用贴剂。静电纺丝参数：电压15kv，纺丝速度1ml/h，接收距离20cm，相对湿度为30％。将制得的外用贴剂进行药物释放实验，齐墩果酸的药物释放曲线如图10所示。
实施例2
(1)将80重量份数聚环氧乙烷、10重量份数丙二醇及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为7wt％的纺丝溶液。
(2)将上述纺丝溶液装入注射器，置于静电纺丝设备上进行纺丝，即得聚环氧乙烷纤维膜，其结构如附图2所示。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm，收集之后加盖衬材料，既得聚环氧乙烷纤维膜空白贴剂。静电纺丝参数：电压15kv，纺丝速度1ml/h，接收距离20cm，相对湿度为30％。
实施例3
(1)将80重量份数聚环氧乙烷、50重量份数栀子苷、10重量份数丙二醇及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为10wt％的纺丝溶液。
(2)将上述纺丝溶液装入注射器，置于静电纺丝设备上进行纺丝，即得含药纳米纤维膜，其结构如附图3所示。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm，收集之后加盖衬材料，既得亲水性纤维膜含药外用贴剂。静电纺丝参数：电压15kv，纺丝速度1.0ml/h，接收距离20cm，相对湿度为30％。将制备的外用贴剂做药物释放实验，栀子苷的药物释放曲线如图11所示。
实施例4
(1)将80重量份数SIS热塑弹性体、80重量份数石油树脂、10重量份数丙二醇、50重量份数齐墩果酸及1重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷和汽油的混合溶剂(其中四氢呋喃与环己烷以及汽油三者的质量比为2:1:1)中充分溶解，制备固体浓度为16wt％的纺丝溶液。
(2)将80重量份数聚环氧乙烷、50重量份数栀子苷、20重量份数丙二醇及4重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为10wt％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同数量的注射器中，置于静电纺丝设备上进行混合纺丝，即得含药聚环氧乙烷/SIS压敏胶复合纤维膜，其结构如附图4所示。其中装有SIS压敏胶溶液的注射器与装有亲水性药物注射器的数量比为4:3。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm。静电纺丝参数：电压15kv，含热熔压敏胶纺丝液的注射器纺丝速度为1.0ml/h，含环氧乙烷纺丝液的注射器的纺丝速度为0.5ml/h，接收距离20cm，相对湿度为30％。将制备的外用贴剂做药物释放实验，齐墩果酸的药物释放曲线如图10所示，栀子苷的药物释放曲线如图11所示。
通过实例四与实例一和实例三对比可以发现，成功制备了结构适宜的双亲性外用贴剂，且制备的双亲性外用贴剂的亲脂性药物的释放效果与单纯含药的SIS压敏胶纤维外用贴剂的释放效果基本持平，亲水性药物的释放效果与单纯含药的聚环氧乙烷外用贴剂基本相当。所以，这种双亲型的外用贴剂达到了预期要求。
实施例5
(1)将170重量份数SBS热塑弹性体、25重量份数萜烯树脂、10重量份数丙二醇、10重量份数甘草次酸及2重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷混合溶剂(其中四氢呋喃与环己烷的质量比为3:1)中充分溶解，制备固体浓度为8wt％的纺丝溶液。
(2)将145重量份数聚环氧乙烷、145重量份数栀子苷、10重量份数丙二醇及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为8％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同数量的注射器中，置于静电纺丝设备上进行混合纺丝，即得含栀子苷聚环氧乙烷/载药SBS压敏胶复合纤维膜，其结构如附图5所示。其中含药SBS压敏胶溶液的注射器与含药环氧乙烷溶液的注射器数量之比为6:1，纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm。静电纺丝参数：电压20kv，纺丝速度2.0ml/h，接收距离15cm，相对湿度为40％。
实施例6
(1)将30重量份数SEBS热塑弹性体、170重量份数石油树脂、20重量份数乙醇、20重量份数甘草次酸及4重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷混合溶剂(其中四氢呋喃与环己烷的质量比为3:1)中充分溶解，制备固体浓度为30wt％的纺丝溶液。
(2)将100重量份数聚乙烯醇、10重量份数熊果苷、10重量份数丙二醇及1重量份数N,N-二丁基氨基二硫代甲酸锌，在水中充分溶解，制备固体浓度为30％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同的注射器，置于静电纺丝设备上进行混合纺丝，即得含熊果苷聚乙烯醇/载药SEBS压敏胶复合纤维膜，其结构如附图6所示。其中含药SEBS压敏胶溶液的注射器与含药聚乙烯醇溶液的注射器数量之比为1:6。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为200±20μm。静电纺丝参数：电压20kv，装有热熔压敏胶溶液注射器纺丝速度1.0ml/h，装有环氧乙烷纺丝液注射器的纺丝速度0.5ml/h，接收距离20cm,相对湿度为30％。
实施例7
(1)将70重量份数SEPS热塑弹性体、50重量份数萜烯树脂、10重量份数乙醇、15重量份数齐墩果酸及2重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷和汽油的混合溶剂(其中四氢呋喃与环己烷以及汽油三者的质量比为2:1:1)中充分溶解，制备固体浓度为20wt％的纺丝溶液。
(2)将50重量份数聚乙烯醇、30重量份数栀子苷、10重量份数乙醇及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为15％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同数量的注射器中，置于静电纺丝设备上进行混合纺丝，即得含栀子苷聚乙烯醇/SEPS压敏胶复合纤维膜，其结构如附图7所示。其中含药SEPS压敏胶溶液的注射器与含聚乙烯醇溶液的注射器数量之比为5:2。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为400±20μm。静电纺丝参数：电压20kv，纺丝速度0.5ml/h，接收距离10cm,相对湿度为22％。
实施例8
(1)将80重量份数SEPS热塑弹性体、80重量份数松香、10重量份数乙醇、145重量份数齐墩果酸及2重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃、环己烷和汽油的混合溶剂(其中四氢呋喃与环己烷以及汽油三者的质量比为2:1:1)中充分溶解，制备固体浓度为35wt％的纺丝溶液。
(2)将50重量份数多糖、130重量份数栀子苷、10重量份数乙醇及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为15％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同数量的注射器中，置于静电纺丝设备上进行混合纺丝，即得含栀子苷多糖/SEPS压敏胶复合纤维膜，其结构如附图8所示。其中含药SEPS压敏胶溶液的注射器与含药多糖溶液的注射器数量之比为3:4。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为300±20μm。静电纺丝参数：电压18kv，纺丝速度0.5ml/h，接收距离10cm,相对湿度为22％。
实施例9
(1)将175重量份数SBS热塑弹性体、25重量份数松香、10重量份数乙醇、30重量份数咖啡因及2重量份数N,N-二丁基氨基二硫代甲酸锌，在四氢呋喃溶剂中充分溶解，制备固体浓度为6wt％的纺丝溶液。
(2)将50重量份数多糖、130重量份数栀子苷、20重量份数芍药苷及2重量份数N,N-二丁基氨基二硫代甲酸锌，在水和乙醇的混合溶剂(其中水和乙醇的质量比为3:7)中充分溶解，制备固体浓度为35％的纺丝溶液。
(3)将上述两种纺丝溶液装入不同的注射器，置于静电纺丝设备上进行混合纺丝，即得含芍药苷多糖/SBS压敏胶复合纤维膜，其结构如附图9所示。其中含药SBS压敏胶溶液的注射器与含药多肽溶液的注射器数量之比为4:3。纺丝收集方式为平板收集或转鼓收集，接收平板或转鼓的表面贴有背衬材料，接收厚度为300±20μm。静电纺丝参数：电压20kv，纺丝速度1ml/h，接收距离15cm,相对湿度为22％。
Claims (10)
1.一种基于静电纺丝的压敏胶贴剂，其特征在于，所述的压敏胶贴剂的主体组成包括苯乙烯系压敏胶纤维丝和释放亲水性药物的纤维丝，所述的苯乙烯系压敏胶纤维丝包括苯乙烯系热塑性弹性体、亲脂性药物、增粘剂、透皮促渗剂、抗氧剂，所述的释放亲水性药物的纤维丝包括亲水性基质、亲水性药物、透皮促渗剂、抗氧剂；
所述的苯乙烯系压敏胶纤维丝中各组分的重量份数为：
所述的释放亲水性药物的纤维丝中各组分的重量份数为：
所述苯乙烯系热塑弹性体为SBS、SIS、SEBS、SEPS中的一种或几种；所述亲水性基质为聚环氧乙烷、聚乙烯醇、多糖或其组合物；所述的增粘剂选自石油树脂、萜烯树脂、松香或其组合物。
2.根据权利要求1所述的一种基于静电纺丝的压敏胶贴剂，其特征在于，所述亲脂性药物为能够满足透皮给药要求的亲脂性单一组分药物或多组分药物的复配物。
3.根据权利要求1或2所述的一种基于静电纺丝的压敏胶贴剂，其特征在于，所述的亲水性药物为能够满足透皮给药要求的亲水性单一组分药物或多组分药物的复配物。
4.根据权利要求1或2所述的一种基于静电纺丝的压敏胶贴剂，其特征在于，所述透皮促渗剂为乙醇、丙二醇或其组合物；所述抗氧剂为N,N-二丁基氨基二硫代甲酸锌、橡胶促进剂或其组合物。
5.根据权利要求3所述的一种基于静电纺丝的压敏胶贴剂，其特征在于，所述透皮促渗剂为乙醇、丙二醇或其组合物；所述抗氧剂为N,N-二丁基氨基二硫代甲酸锌、橡胶促进剂或其组合物。
6.权利要求1-5任一所述的基于静电纺丝的压敏胶贴剂的制备方法，其特征在于以下步骤：
(1)将20～180重量份数苯乙烯系热塑弹性体、20～180重量份数增粘剂、5～75重量份数透皮促渗剂、5～150重量份数亲脂性药物及1～5重量份数抗氧剂，在混合溶剂A中充分溶解，制备固体浓度为5～35wt％的纺丝溶液,其中苯乙烯系热塑性弹性体与增粘剂的比例为9:1～1:9；
(2)将80～150重量份数亲水性基质、5～150重量份数亲水性药物、5～65重量份数透皮促渗剂及1～5重量份数抗氧剂，在混合溶剂B中充分溶解，制备固体浓度为5～35wt％的纺丝溶液；
(3)将两种纺丝溶液分别装入不同数量的注射器中，置于静电纺丝设备上进行静电纺丝，含苯乙烯系压敏胶溶液的注射器与含亲水性药物溶液注射器的数量比为6:1～1:6，采用平板收集或转鼓收集的方式收集纺丝，接收平板或转鼓的表面贴有背衬材料，接收厚度为100±20μm～400±20μm，收集之后加盖衬材，即 得到双亲性外用压敏胶贴剂。
7.根据权利要求6所述的制备方法，其特征在于，所述的静电纺丝参数为：电压10～25kV，纺丝速度0.3～2.0ml/h，接收距离8～25cm，相对湿度为20～50％。
8.根据权利要求6所述的制备方法，其特征在于，所述的混合溶剂A为甲苯、己烷、四氢呋喃、N,N-二甲基甲酰胺、环己烷、汽油、醋酸乙烯酯、油脂中的一种或几种组成。
9.根据权利要求6所述的制备方法，其特征在于，所述的混合溶剂B为四氢呋喃、N,N-二甲基甲酰胺、水、乙醇、乙酸、甲酸、醋酸乙烯酯中的一种或几种组成。
10.根据权利要求6所述的制备方法，其特征在于，所述的背衬材料为棉布、无纺布或纸；所述盖衬材料为防粘纸、塑料薄膜、铝箔-聚乙烯复合膜或硬质纱布。
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