CN108498854A - 一种负载纳米缓释药物胶束和载银微球的膨胀海绵及其制备方法及用途 - Google Patents
一种负载纳米缓释药物胶束和载银微球的膨胀海绵及其制备方法及用途 Download PDFInfo
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Abstract
本发明属于止血材料技术领域,涉及生物医用高分子材料及化学交联海绵及改性领域,具体涉及一种负载纳米缓释药物胶束的膨胀海绵、制备方法及用途,包括膨胀海绵本体,膨胀海绵本体含有纳米缓释药物胶束和载银微球,本发明具有止血、抗菌和长效药物缓释功能,在鼻腔止血和促进创面功能修复方面具有重要的应用前景。
Description
技术领域
本发明属于止血材料技术领域,涉及生物医用高分子材料及化学交联海绵及改性领域,具体涉及一种负载纳米缓释药物胶束的膨胀海绵、制备方法及用途。
背景技术
目前,临床耳鼻喉科在鼻腔出血止血手术中,多数使用凡士林纱布条、明胶海绵、碘仿纱布进行填塞止血。有些止血海绵,例如明胶海绵经过鼻腔液体的浸润,能够迅速膨胀,对出血部位进行有效压迫,达到物理压迫止血的目的。但是,若是在鼻腔膨胀过度,会造成鼻腔堵塞,引发患者及其不适应的症状。聚乙烯醇缩醛海绵,具有很好的吸收液体的能力,吸收倍率可达5-30倍,与传统的止血材料相比,聚乙烯醇类止血海绵的止血、膨胀、拉伸、收缩等物理化学性能存在很多的优势,因子,此类海绵在医用领域,尤其是在鼻腔止血领域得到了广泛的应用内。
然而,止血海绵在完成止血后,海绵的自身性能对于创面功能的恢复也起到了重要的作用。为此,需要在完成止血功能后,创面的止血海绵应该能具有更好的创面修复功能。目前在已有专利CN104784738A公布了海绵中直接添加药物,通过海绵的缓释,来提高海绵的综合性能。为了延长海绵的止血性能和壳聚糖微球负载药物(CN101590288A)进行药物缓释的海绵。
然而,在鼻腔止血和功能修复领域,仍然缺乏一种具有止血抗菌功能和调控受损部位组织修复功能的膨胀海绵。
发明内容
针对现有的技术不足,本发明提供一种负载纳米缓释药物胶束和载银微球的膨胀海绵及其制备方法及用途。
为了实现上述目的,本发明所采取的技术方案是:一种负载纳米缓释药物胶束和载银微球的膨胀海绵,包括膨胀海绵本体,其特征在于,膨胀海绵本体含有纳米缓释药物胶束和载银微球。
一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,该方法包括如下步骤:
(1)制备纳米缓释药物胶束液体
将1-10mg两亲性嵌段共聚物,0.01-2mg疏水性药物溶于1-5mL有机溶剂中制成聚合物溶液,以滴速为0.01-0.10mL/min滴入搅拌速率为400-2000rpm且容量为10-100mL的超纯水中,再在400-2000rpm的速率下继续搅拌24-48h,最后通过蒸发溶剂得到含有粒径为120-220nm的纳米缓释药物胶束液体;
(2)制备载银微球
室温条件下,将1-4g粒径1-10μm的二氧化硅加入到5-20mL且浓度为7.0×10-2mol/L的AgNO3溶液中,以速率为200-300rpm搅拌10-50min,得到二氧化硅悬浊液,将所得悬浊液升温至60℃,以速率为200-300rpm搅拌下,加入10-60mL混合液,等5-20min后,降至室温,所得产物用超纯水清洗3-5次,通过抽滤后所得固体在30-45℃真空干燥24-36h,得到载银微球;
(3)制作压缩海绵
取1-5g的PVA溶于19mL-28.3mL的超纯水中,配置成浓度为5%-15%的水溶液,加入0.1-3g载银微球,加入0.1-5g海藻酸钠和0.1-2.5g的十二烷基硫酸钠,在60-90℃,200-800rpm条件下搅拌0.5-6h;当温度降至20-30℃,加入2-20mL浓度为1mol/L的盐酸溶液,控制搅拌速率为200-300rpm,搅拌30-90min,加入2-10g浓度为50%戊二醛溶液,控制搅拌速率为200-300rpm,搅拌2-10min;升温至35℃-40℃,反应1-5h;将所得海绵用1-2L超纯水冲洗3-5次,将裁剪合适的海绵放入模具,压缩后的海绵通过烘箱50-80℃干燥24-30h,得到负载载银微球且压缩倍率为5-20倍的压缩海绵;
(4)制作膨胀海绵
将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为1%-10%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度20%-30%,电压为(+15kV)~(+18kV),(-0.5kV)~(-1.5kV),接收器距离为10-20cm,将1-10mL纳米缓释药物胶束溶液,以2-5mL/h速率推进,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束和载银微球的膨胀海绵。
所述两亲性两嵌段共聚物为mPEG-b-PLLA,mPEG-b-PLGA,mPEG-b-PCL,mPEG-b-PPDO,其中,mPEG为分子量为数均分子量为500-5000的端甲基聚乙二醇,PLLA为数均分子量分子量为5000-20000的聚L型聚乳酸,PLGA为数均分子量为5000-20000的聚乳酸乙醇酸共聚物,其中乙交酯和丙交酯的比例为70-80:30-20,PCL为数均分子量为5000-20000的聚-ε-己内酯,PPDO为数均分子量为5000-20000的聚对二氧环己酮。
所述疏水性药物为二丙酸倍他米松酯、阿霉素和伊达比星中的至少一种。
所述有机溶剂为四氢呋喃、N,N-二甲基甲酰胺、体积比为(1-3):1的四氢呋喃与N,N-二甲基甲酰胺的混合液。
所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
所述PVA为1797型、1799型、1788型、PVA-117型中的至少一种,所述海藻酸钠粘度为200±20mPa.s。
一种负载纳米缓释药物胶束和载银微球的膨胀海绵的用途,其特征在于,该海绵含有纳米缓释药物胶束和载银微球,其应用于鼻腔止血和功能恢复中的应用。
本发明的有益效果:本发明具有止血、抗菌和长效药物缓释功能,在鼻腔止血和促进创面功能修复方面具有重要的应用前景。
附图说明
图1为本发明膨胀海绵经过冷冻干燥后,多孔结构电子扫描显微镜图;
图2为本发明测得纳米缓释药物胶束所带电荷及电位大小(-22mV);
图3为本发明压缩海绵的SEM图;
图4为本发明负载纳米缓释药物胶束的膨胀海绵表面喷涂纳米缓释药物胶束后表面结构的电子扫描显微镜图;
具体实施方式
如图1-图4所示,实施例1,一种负载纳米缓释药物胶束和载银微球的膨胀海绵,是由纳米缓释药物胶束、载银微球和膨胀海绵构成。其制备方法如下:
(1)将10mg两亲性嵌段共聚物,2mg疏水性药物溶于5mL有机溶剂中制成聚合物溶液,在滴速为0.10mL/min滴入搅拌速率为2000rpm的100mL的超纯水中,再在2000rpm搅拌48h,蒸发溶剂,得到含有粒径为220nm的纳米缓释药物胶束液体。
所述两亲性两嵌段共聚物为mPEG-b-PLGA,其中,mPEG为分子量为数均分子量为5000的端甲基聚乙二醇,PLGA为数均分子量为20000的聚乳酸乙醇酸共聚物,其中乙交酯和丙交酯的比例为80:20。
所述疏水性药物为二丙酸倍他米松酯。
所述有机溶剂为四氢呋喃。
(2)室温条件下,将4g粒径10μm的二氧化硅加入到20mL的浓度为7.0×10-2mol/L的AgNO3溶液中,300rpm搅拌50min,得到二氧化硅悬浊液。将所得悬浊液升温至60℃,300rpm搅拌条件下,加入60mL混合液,20min后,降至室温。所得产物用超纯水清洗5次,抽滤,所得固体45℃真空干燥36h,得到载银微球。
所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
(3)取5g的PVA溶于28.3mL的超纯水中,配置成浓度为15%的水溶液,加入3g载银微球,加入5g海藻酸钠,加入2.5g的十二烷基硫酸钠。90℃,800rpm条件下搅拌6h。温度降至30℃,加入20mL浓度为1mol/L的盐酸溶液,300rpm搅拌,90min,加入10g浓度为50%戊二醛溶液,300rpm搅拌10min。升温至40℃,反应5h。将所得海绵(图1所示为膨胀海绵经过冷冻干燥后,多孔结构电子扫描显微镜图)用2L超纯水冲洗5次,将裁剪合适的海绵放入模具,压缩后,在80℃烘箱干燥中30h,得到负载载银微球的压缩海绵。所得海绵的压缩倍率为20倍。
所述1799型。所述海藻酸钠粘度为200±20mPa.s。
(4)将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为10%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度30%,电压为(+18kV),~(-1.5kV),接收器距离为20cm,将10mL纳米缓释药物胶束溶液,以5mL/h推进速率,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束的膨胀海绵。
实施例2,一种负载纳米缓释药物胶束和载银微球的膨胀海绵,是由纳米缓释药物胶束、载银微球和膨胀海绵构成。其制备方法如下:
(1)将1mg两亲性嵌段共聚物,0.01疏水性药物溶于1mL有机溶剂中制成聚合物溶液,在滴速为0.01mL/min滴入搅拌速率为400rpm的10mL的超纯水中,再在400rpm搅拌24h,蒸发溶剂,得到含有粒径为120nm的纳米缓释药物胶束液体,所带电位为-22mV(图2所示为测得纳米缓释药物胶束所带电荷及电位大小(-22mV))。
所述两亲性两嵌段共聚物为mPEG-b-PPDO,其中,mPEG为分子量为数均分子量为500的端甲基聚乙二醇,PPDO为数均分子量为5000的聚对二氧环己酮。
所述疏水性药物为阿霉素。
所述有机溶剂为体积比为(1-3):1的四氢呋喃与N,N-二甲基甲酰胺的混合液。
(2)室温条件下,将1g粒径1μm的二氧化硅加入到5mL的浓度为7.0×10-2mol/L的AgNO3溶液中,200rpm搅拌10min,得到二氧化硅悬浊液。将所得悬浊液升温至60℃,200rpm搅拌,条件下,加入10mL混合液,5min后,降至室温。所得产物用超纯水清洗3次,抽滤,所得固体30℃真空干燥24h,得到载银微球。
所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
(3)取1g的PVA溶于19mLmL的超纯水中,配置成浓度为5%的水溶液,加入0.1g载银微球,加入0.1g海藻酸钠,加入0.1g的十二烷基硫酸钠。60℃,200rpm条件下搅拌0.5h。温度降至20℃,加入2mL浓度为1mol/L的盐酸溶液,搅拌200rpm,30min,加入2g浓度为50%戊二醛溶液,200rpm搅拌2min。升温至35℃,反应1h。将所得海绵用1L超纯水冲洗3次,将裁剪合适的海绵放入模具,压缩后,在50℃烘箱干燥中24h,得到负载载银微球的压缩海绵。所得海绵的压缩倍率为5倍。
所述PVA为PVA-117型。所述海藻酸钠粘度为200±20mPa.s。
(4)将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为1%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度20%,电压为(+15kV),(-0.5kV),接收器距离为10cm,将1mL纳米缓释药物胶束溶液,以2mL/h推进速率,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束的膨胀海绵。
实施例3,一种负载纳米缓释药物胶束和载银微球的膨胀海绵,其特征是由纳米缓释药物胶束、载银微球和膨胀海绵构成。其制备方法,其特征是用下述方法制成:
(1)将5mg两亲性嵌段共聚物,1mg疏水性药物溶于3mL有机溶剂中制成聚合物溶液,在滴速为0.05mL/min滴入搅拌速率为1000rpm的50mL的超纯水中,再在1800rpm搅拌30h,蒸发溶剂,得到含有粒径为180nm的纳米缓释药物胶束液体。
所述两亲性两嵌段共聚物为mPEG-b-PLLA,mPEG为分子量为数均分子量为4000的端甲基聚乙二醇,PLLA为数均分子量分子量为5000-20000的聚L型聚乳酸。
所述疏水性药物为伊达比星。所述有机溶剂为N,N-二甲基甲酰胺。
(2)室温条件下,将3g粒径7μm的二氧化硅加入到12mL的浓度为7.0×10-2mol/L的AgNO3溶液中,220rpm搅拌30min,得到二氧化硅悬浊液。将所得悬浊液升温至60℃,260rpm搅拌,条件下,加入40mL混合液,15min后,降至室温。所得产物用超纯水清洗3次,抽滤,所得固体40℃真空干燥30h,得到载银微球。
所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
(3)取5g的PVA溶于28.3mL的超纯水中,配置成浓度为15%的水溶液,加入2g载银微球,加入2g海藻酸钠,加入2g的十二烷基硫酸钠。70℃,500rpm条件下搅拌3h。温度降至25℃,加入15mL浓度为1mol/L的盐酸溶液,搅拌250rpm,60min,加入8g浓度为50%戊二醛溶液,260rpm搅拌7min。升温至38℃,反应2h。将所得海绵用1.5L超纯水冲洗4次,将裁剪合适的海绵放入模具,压缩后,在60℃烘箱干燥中28h,得到负载载银微球的压缩海绵。所得海绵的压缩倍率为15倍(图3所示为压缩海绵的SEM图)。
所述PVA为质量比为3:1的1788型和PVA-117型。所述海藻酸钠粘度为200±20mPa.s。
(4)将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为5%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度25%,电压为(+15kV),(-0.5kV),接收器距离为15cm,将8mL纳米缓释药物胶束溶液,以3mL/h推进速率,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束的膨胀海绵。
实施例4,一种负载纳米缓释药物胶束和载银微球的膨胀海绵,其特征是由纳米缓释药物胶束、载银微球和膨胀海绵构成。其制备方法,其特征是用下述方法制成:
(1)将8mg两亲性嵌段共聚物,1.5mg疏水性药物溶于3mL有机溶剂中制成聚合物溶液,在滴速为0.05mL/min滴入搅拌速率为400rpm的10mL的超纯水中,再在600rpm搅拌48h,蒸发溶剂,得到含有粒径为160nm的纳米缓释药物胶束液体。
所述两亲性两嵌段共聚物为mPEG-b-PCL,mPEG为分子量为数均分子量为2000的端甲基聚乙二醇,PCL为数均分子量为18000的聚-ε-己内酯。
所述疏水性药物为二丙酸倍他米松酯。
所述有机溶剂为四氢呋喃。
(2)室温条件下,将2g粒径1-10μm的二氧化硅加入到10mL的浓度为7.0×10-2mol/L的AgNO3溶液中,200rpm搅拌20min,得到二氧化硅悬浊液。将所得悬浊液升温至60℃,200rpm搅拌,条件下,加入40mL混合液,10min后,降至室温。所得产物用超纯水清洗3次,抽滤,所得固体30℃真空干燥24h,得到载银微球。
所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
(3)取1g的PVA溶于19mLmL的超纯水中,配置成浓度为5%的水溶液,加入0.1g载银微球,加入0.1g海藻酸钠,加入0.1g的十二烷基硫酸钠。90℃,200rpm条件下搅拌2h。温度降至24℃,加入10mL浓度为1mol/L的盐酸溶液,搅拌300rpm,30min,加入2-g浓度为50%戊二醛溶液,200rpm搅拌6min。升温至40℃,反应1h。将所得海绵用1L超纯水冲洗3次,将裁剪合适的海绵放入模具,压缩后,在50℃烘箱干燥中24h,得到负载载银微球的压缩海绵。所得海绵的压缩倍率为10倍。
所述PVA为1788型。所述海藻酸钠粘度为200±20mPa.s。
(4)将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为5%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度30%,电压为(+18kV),(-0.5kV),接收器距离为10cm,将5mL纳米缓释药物胶束溶液,以3mL/h推进速率,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束的膨胀海绵(图4所示为负载纳米缓释药物胶束的膨胀海绵表面喷涂纳米缓释药物胶束后,表面结构的电子扫描显微镜图)。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本领域内普通的技术人员的简单更改和替换都是本发明的保护范围之内。
Claims (8)
1.一种负载纳米缓释药物胶束和载银微球的膨胀海绵,包括膨胀海绵本体,其特征在于,膨胀海绵本体含有纳米缓释药物胶束和载银微球。
2.一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,该方法包括如下步骤:
(1)制备纳米缓释药物胶束液体
将1-10mg两亲性嵌段共聚物,0.01-2mg疏水性药物溶于1-5mL有机溶剂中制成聚合物溶液,以滴速为0.01-0.10mL/min滴入搅拌速率为400-2000rpm且容量为10-100mL的超纯水中,再在400-2000rpm的速率下继续搅拌24-48h,最后通过蒸发溶剂得到含有粒径为120-220nm的纳米缓释药物胶束液体;
(2)制备载银微球
室温条件下,将1-4g粒径1-10μm的二氧化硅加入到5-20mL且浓度为7.0×10-2mol/L的AgNO3溶液中,以速率为200-300rpm搅拌10-50min,得到二氧化硅悬浊液,将所得悬浊液升温至60℃,以速率为200-300rpm搅拌下,加入10-60mL混合液,等5-20min后,降至室温,所得产物用超纯水清洗3-5次,通过抽滤后所得固体在30-45℃真空干燥24-36h,得到载银微球;
(3)制作压缩海绵
取1-5g的PVA溶于19mL-28.3mL的超纯水中,配置成浓度为5%-15%的水溶液,加入0.1-3g载银微球,加入0.1-5g海藻酸钠和0.1-2.5g的十二烷基硫酸钠,在60-90℃,200-800rpm条件下搅拌0.5-6h;当温度降至20-30℃,加入2-20mL浓度为1mol/L的盐酸溶液,控制搅拌速率为200-300rpm,搅拌30-90min,加入2-10g浓度为50%戊二醛溶液,控制搅拌速率为200-300rpm,搅拌2-10min;升温至35℃-40℃,反应1-5h;将所得海绵用1-2L超纯水冲洗3-5次,将裁剪合适的海绵放入模具,压缩后的海绵通过烘箱50-80℃干燥24-30h,得到负载载银微球且压缩倍率为5-20倍的压缩海绵;
(4)制作膨胀海绵
将步骤(1)所得纳米缓释药物胶束液体,制成质量浓度为1%-10%的纳米缓释药物胶束液体,采用静电纺丝设备,在设定空气为湿度20%-30%,电压为(+15kV)~(+18kV),(-0.5kV)~(-1.5kV),接收器距离为10-20cm,将1-10mL纳米缓释药物胶束溶液,以2-5mL/h速率推进,喷涂在步骤(2)所得压缩海绵表面,得到一种负载纳米缓释药物胶束和载银微球的膨胀海绵。
3.如权利要求2所述的一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,其特征在于,所述两亲性两嵌段共聚物为mPEG-b-PLLA,mPEG-b-PLGA,mPEG-b-PCL,mPEG-b-PPDO,其中,mPEG为分子量为数均分子量为500-5000的端甲基聚乙二醇,PLLA为数均分子量分子量为5000-20000的聚L型聚乳酸,PLGA为数均分子量为5000-20000的聚乳酸乙醇酸共聚物,其中乙交酯和丙交酯的比例为70-80:30-20,PCL为数均分子量为5000-20000的聚-ε-己内酯,PPDO为数均分子量为5000-20000的聚对二氧环己酮。
4.如权利要求2所述的一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,其特征在于,所述疏水性药物为二丙酸倍他米松酯、阿霉素和伊达比星中的至少一种。
5.如权利要求2所述的一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,其特征在于,所述有机溶剂为四氢呋喃、N,N-二甲基甲酰胺、体积比为(1-3):1的四氢呋喃与N,N-二甲基甲酰胺的混合液。
6.如权利要求2所述的一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,其特征在于,所述混合液为浓度为6.0×10-2mol/L的葡萄糖溶液和3.2×10-2mol/L的NaOH混合溶液。
7.如权利要求2所述的一种负载纳米缓释药物胶束和载银微球的膨胀海绵的制备方法,其特征在于,所述PVA为1797型、1799型、1788型、PVA-117型中的至少一种,所述海藻酸钠粘度为200±20mPa.s。
8.一种负载纳米缓释药物胶束和载银微球的膨胀海绵的用途,其特征在于,该海绵含有纳米缓释药物胶束和载银微球,其应用于鼻腔止血和功能恢复中的应用。
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