CN113679693A - 一种雾化式可溶性抗菌消炎微针贴片的制备方法 - Google Patents
一种雾化式可溶性抗菌消炎微针贴片的制备方法 Download PDFInfo
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Abstract
本发明公开了一种雾化式可溶性抗菌消炎微针贴片的制备方法,该微针采用高效喷雾一体化技术,包括微针主体和微针背衬粘附层,其中所述的微针主体为含有抗菌成分与生物相容性材料制备,微针背衬粘附层为TPU医用胶带。该可溶性微针的制备新方法摒弃了真空与离心的耗时操作,只需要喷雾数秒即可制备完成,节约了制备时间,提高了微针制备效率,同时减小了粘度对微针制备的限制,这为可溶性微针的大规模生产提供了可行性方案。基于无痛微创的可溶性微针透皮技术通过高效喷雾一体化技术,将抗菌成分负载于微针针体内,制备成可溶性抗菌消炎微针贴片,从而使得抗菌消炎变得便捷高效。由于本发明制备的可溶性微针,所以不会产生环境污染,绿色环保。
Description
技术领域
本发明属于微针领域,具体涉及一种雾化式可溶性抗菌消炎微针贴片的制备方法。
背景技术
硅微针和金属微针容易断裂,因此会引起皮肤的感染与不适。为了避免这种事情的发生,研究人员对微针进行了全新的设计与制备,可溶性微针由此诞生。可溶性微针的优势不仅在于其不会引发皮肤的感染,还在于其可以进行载药进行药物的缓释,并且不会产生二次工业废物,极大的降低了处理成本。
目前常用的可溶性微针的制备方式分为两种:真空模具塑型法和离心模具塑型法。首先,无论是真空模具塑型法还是离心模具塑型法,其所需的真空时间和离心时间都需要至少5~20min。因此,所需时间较长。其次,此两种方法对溶液粘度的要求很高,即溶液过黏会影响可溶性微针的制备效率和微针的质量。最后,对于微针的制备效率,此二法也具有局限性,量产所需的设备将十分庞大。
抗菌消炎中的一种给药方式是肌肉注射,这会引起患者的恐惧、疼痛、感染或皮肤损伤,并需要经过培训的工作人员进行用药。然而,可溶性微针贴片普遍被大多数患者所接受,因为对于一些患者的适应症来说,在皮肤上“贴个贴片”比皮下注射“打一针”更方便和有效率。
根据上述目前微针制备存在的问题,人们亟需一种简单便捷、高效制备、可大规模生产的可溶性微针制备的新方法。
发明内容
本发明针对上述目前可溶性微针制备过程中存在的问题,以及人们对使用更温和的方式,进行抗菌消炎的需求,提供一种雾化式可溶性抗菌消炎微针贴片的制备方法。本发明不仅可以高效规模化的生产可溶性微针,还具有较好的抗菌消炎性能,其生产的便捷性为可溶性抗菌消炎微针微针贴片的大规模生产提供了新的可行性方案。
为解决上述的技术问题,满足上述的技术要求,本发明采用如下技术方案:
(1)抗菌液的配置:将质量分数为30% ~ 50% 的抗菌成分加入到适量的60% 的乙醇水溶液中,室温下搅拌至其充分溶解,抗菌液制备完成;
(2)微针基体液的配置:将海藻酸钠、羟丙基甲基纤维素依次加入到适量的60% 的乙醇水溶液中,将其密封加热至70℃,匀速搅拌至溶解完全,静置冷却至37℃后,依次加入聚乙烯基吡咯烷酮和透明质酸,继续匀速搅拌至溶液澄清透明,微针基体液制备完成;
(3)微针前驱液的配置:将抗菌液与微针基体液按照一定比例搅拌混合均匀,静置除泡备用;
(4)可溶性抗菌微针的制备:抽取5ml 微针前驱液,连接在双介质喷嘴的进料口上,将高压气罐接在进气口上,调好适当出气压力和微针前驱液推进速度,将喷嘴对准PDMS微针模具,打开喷嘴开关,进行雾化制备微针,5s后关闭开关,取出微针模具,干燥10h,脱模。将TPU医用胶布贴在微针背衬上,制成可溶性抗菌微针贴片。
作为本发明的一种优选,所述的微针前驱液中抗菌液与微针基体液的体积比为1-4:4-9。
作为本发明的一种优选,所述的可溶性抗菌消炎微针的制备中,出气气压为0.05~0.3Mpa,干燥温度为30~35℃。
作为本发明的一种优选,所述的微针为圆锥形、四棱锥形。
作为本发明的一种优选,所述的微针针长为100~300μm,微针间距为400~800μm,圆锥针体根部直径为200~300μm,四棱锥针体根部边长为200~400μm。
本发明具有以下有益效果:
1.雾化式可溶性微针的制备过程只需要喷雾数秒即可制备完成,节约了大量的制备时间,提高了微针的制备效率,同时减小了粘度对微针制备的限制,并且为可溶性微针的大规模生产提供了可行性方案;
2.该可溶性抗菌消炎微针贴片通过无痛微创的可溶性微针透皮技术将广谱抗菌的抗菌成分负载于微针针体内,从而使得抗菌消炎的过程变得便捷高效。由于本发明为可溶性微针,所以不会产生诸如注射钢针这类生物有害废物,绿色环保。
附图说明:
图1为具体实施方式所述的雾化式可溶性抗菌消炎微针贴片的制备示意图;
图2为实施例1所制备的雾化式可溶性抗菌消炎微针贴片的光学显微镜示意图。
具体实施方式:
下面将结合具体实施例对本发明的技术方案进行进一步的描述。需理解为以下实施例仅为简明易懂的解释本发明,而不应被理解为对本发明保护范围的限制。凡基于本发明上述内容所应用的技术原理和创新,均涵盖在本发明旨在保护的范围内。
本发明若未特指,以下实施例中所用原材料和试剂均为市场正规销售产品,或者可以通过已经熟知的方法进行常规制备。
如图1所示,本发明中的化式可溶性抗菌消炎微针贴片的制备方法,包括如下步骤:
(1)抗菌液的配置:将质量分数为30% ~ 50% 的抗菌成分加入到适量的60% 的乙醇水溶液中,室温下搅拌至其充分溶解,抗菌液制备完成;
(2)微针基体液的配置:将海藻酸钠、羟丙基甲基纤维素依次加入到适量的60% 的乙醇水溶液中,将其密封加热至70℃,匀速搅拌至溶解完全,静置冷却至37℃后,依次加入聚乙烯基吡咯烷酮和透明质酸,继续匀速搅拌至溶液澄清透明,微针基体液制备完成;
(3)微针前驱液的配置:将抗菌液与微针基体液按照一定比例搅拌混合均匀,静置除泡备用。优选所述的微针前驱液中抗菌液与微针基体液的体积比为1-4:4-9;
(4)可溶性抗菌微针的制备:抽取5ml 微针前驱液,连接在双介质喷嘴的进料口上,将高压气罐接在进气口上,调好适当出气压力和微针前驱液推进速度,将喷嘴对准PDMS微针模具,打开喷嘴开关,进行雾化制备微针,5s后关闭开关,取出微针模具,干燥10h,脱模。将TPU医用胶布贴在微针背衬上,制成可溶性抗菌微针贴片。优选的出气气压为0.05~0.3Mpa,干燥温度为30~35℃,微针针形为圆锥形、四棱锥形,微针针长为100~300μm,微针间距为400~800μm,圆锥针体根部直径为200~300μm,四棱锥针体根部边长为200~400μm。
以下为本发明的具体实施例。
实施例1
一种雾化式可溶性抗菌消炎微针贴片的制备方法,所述方法包括以下步骤:
(1)抗菌液的配置:将质量分数为40% 的抗菌成分加入到适量的60% 的乙醇水溶液中,室温下搅拌至其充分溶解,抗菌液制备完成;
(2)微针基体液的配置:将海藻酸钠、羟丙基甲基纤维素依次加入到适量的60% 的乙醇水溶液中,将其密封加热至70℃,匀速搅拌至溶解完全,静置冷却至37℃后,依次加入聚乙烯基吡咯烷酮和透明质酸,继续匀速搅拌至溶液澄清透明,微针基体液制备完成;
(3)微针前驱液的配置:将抗菌液与微针基体液按照一定比例搅拌混合均匀,静置除泡备用;
(4)可溶性抗菌微针的制备:抽取5ml 微针前驱液,连接在双介质喷嘴的进料口上,将高压气罐接在进气口上,调好适当出气压力和微针前驱液推进速度,将喷嘴对准PDMS微针模具,打开喷嘴开关,进行雾化制备微针,5s后关闭开关,取出微针模具,干燥10h,脱模。将TPU医用胶布贴在微针背衬上,制成可溶性抗菌微针贴片,如图2所示。
上述步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为2:5。
上述步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.08Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为200μm,微针间距为500μm,圆锥针体根部直径为230μm。
实施例2
(1)抗菌液的配置:将质量分数为45% 的抗菌成分加入到适量的60% 的乙醇水溶液中,室温下搅拌至其充分溶解,抗菌液制备完成。
其他步骤同实施例1。
上述步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为3:7。
上述步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为200μm,微针间距为500μm,圆锥针体根部直径为230μm。
实施例3
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为3:9。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为250μm,微针间距为650μm,圆锥针体根部直径为230μm。
实施例4
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为4:5。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.1Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为200μm,微针间距为500μm,圆锥针体根部直径为230μm。
实施例5
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为4:7。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为200μm,微针间距为500μm,圆锥针体根部直径为230μm。
实施例6
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为4:9。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为200μm,微针间距为500μm,圆锥针体根部直径为230μm。
实施例7
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为4:7。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为300μm,微针间距为800μm,四棱锥针体根部边长为240μm。
实施例8
实验方法同实施例2。
其步骤 (3) 中,所述的微针前驱液中抗菌液与微针基体液的体积比为4:9。
其步骤 (4) 中,所述的可溶性抗菌消炎微针的制备中,出气气压为0.2Mpa,干燥温度为35℃。所述的微针为圆锥形。所述的微针针长为300μm,微针间距为800μm,四棱锥针体根部边长为240μm。
Claims (10)
1.一种雾化式可溶性抗菌消炎微针贴片的制备方法,其特征在于,该可溶性抗菌消炎微针贴片采用高效喷雾一体化制备技术,包括微针主体和微针背衬粘附层,其中所述的微针主体为含有抗菌成分与生物相容性材料混合的乙醇水溶液制备,微针背衬粘附层为TPU医用胶带。
2.根据权利要求1所述的雾化式可溶性抗菌消炎微针贴片,其特征在于,所述的抗菌成分包括姜黄素、槲皮素、甘草、聚六亚甲基胍和莫匹罗星中的一种或多种。
3.根据权利要求1所述的雾化式可溶性抗菌消炎微针贴片,其特征在于,所述的生物相容性材料包括聚乙烯基吡咯烷酮、海藻酸钠、透明质酸、羟丙基甲基纤维素。
4.根据权利要求3所述的雾化式可溶性抗菌消炎微针贴片,其特征在于,所述的生物相容性材料中包括以下按重量份计量的各组分:聚乙烯基吡咯烷酮 10~20份、海藻酸钠 1~2份、透明质酸2~5份、羟丙基甲基纤维素 1~3份。
5.根据权利要求3所述的雾化式可溶性抗菌消炎微针贴片,其特征在于,所述的聚乙烯基吡咯烷酮的平均分子量为300000~600000,海藻酸钠的平均分子量为32000~250000,透明质酸的平均分子量为400000~900000,羟丙基甲基纤维素的粘度为400 mpa·s。
6.根据权利要求1~5任一项所述的雾化式可溶性抗菌消炎微针贴片的制备方法,其特征在于,所述的制备方法包括如下步骤:
(1) 抗菌液的配置:将质量分数为30% ~ 50% 的抗菌成分加入到适量的60% 的乙醇水溶液中,室温下搅拌至其充分溶解,抗菌液制备完成;
(2) 微针基体液的配置:将海藻酸钠、羟丙基甲基纤维素依次加入到适量的60% 的乙醇水溶液中,将其密封加热至70℃,匀速搅拌至溶解完全,静置冷却至37℃后,依次加入聚乙烯基吡咯烷酮和透明质酸,继续匀速搅拌至溶液澄清透明,微针基体液制备完成;
(3) 微针前驱液的配置:将抗菌液与微针基体液按照一定比例搅拌混合均匀,静置除泡备用;
(4) 可溶性抗菌微针的制备:抽取5ml 微针前驱液,连接在双介质喷嘴的进料口上,将高压气罐接在进气口上,调好适当出气压力和微针前驱液推进速度,将喷嘴对准PDMS微针模具,打开喷嘴开关,进行雾化制备微针,5s后关闭开关,取出微针模具,干燥10h,脱模,将TPU医用胶布贴在微针背衬上,制成可溶性抗菌微针贴片。
7.根据权利要求6所述的雾化式可溶性抗菌消炎微针贴片,其特征在于,所述的微针前驱液中抗菌液与微针基体液的体积比为1-4:4-9。
8.根据权利要求6所述的该可溶性抗菌消炎微针贴片的制备方法,其特征在于,所述的可溶性抗菌消炎微针的制备中,出气气压为0.05~0.3Mpa,推进速度为2~5ml/h,干燥温度为30~35℃。
9.根据权利要求6所述的该可溶性抗菌消炎微针贴片的制备方法,其特征在于,所述的微针为圆锥形、四棱锥形。
10.根据权利要求6所述的该可溶性抗菌消炎微针贴片的制备方法,其特征在于,所述的微针针长为100~300μm,微针间距为400~800μm,圆锥针体根部直径为200~300μm,四棱锥针体根部边长为200~400μm。
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