CN111686296A - 一种载布地纳德壳聚糖海绵 - Google Patents
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Abstract
本发明公开了一种载布地纳德壳聚糖海绵。本发明制备的海绵孔径分布均匀,大约在200μm左右。通过结合冷冻干燥技术和运用表面活性剂与多糖的高速搅拌制备多孔材料,不仅产品结构均匀,孔隙率高,更增强了其机械强度,有利于加速止血,术腔填塞时可降解并缓释布地奈德抗炎作用。
Description
技术领域
本发明属于生物医用材料领域,涉及一种载布地纳德壳聚糖海绵。
背景技术
CRS是一种与鼻粘膜和鼻窦持续炎症相关的临床综合征,临床上依据鼻息肉是否伴发分为慢性鼻窦炎伴息肉(chronic rhinosinusitis with nasal polyps,CRSwNP)和慢性鼻窦炎不伴息肉(chronic rhinosinusitis without nasal polyps,CRSsNP)两种表型。鼻内镜鼻窦手术(endoscopic sinus surgery,ESS)被广泛认为是治疗CRS的标准方法,但是CRSwNP患者ESS的成功与否很大程度上取决于术后瘢痕、水肿和结痂的减少,因为这些会抑制自然纤毛功能和窦道引流。内镜术后鼻腔鼻窦粘连、窦口狭窄、感染和炎症复发使CRS的治疗策略复杂化,药物洗脱支架、充填物或植入物被认为是解决这些问题的合理选择。目前,国内临床上多单纯采用膨胀海绵或油纱条行鼻腔填塞,术后患者头部胀痛等不适感显著,且黏膜炎性反应和水肿明显,术腔上皮化延迟甚至不上皮化,延长疗程。因此,内镜手术后控制鼻腔黏膜炎性反应对提高临床治愈率及患者的舒适度、满意度尤为重要。
鼻用激素是治疗鼻腔鼻窦黏膜慢性炎症最有效的药物,糖皮质激素能抑制鼻黏膜中嗜酸性粒细胞的活化,具有较强的抗炎作用,可加快鼻窦黏膜功能恢复。布地奈德(budesonide)喷鼻剂是一具有高效局部抗炎作用的糖皮质激素,它能增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性,抑制免疫反应和降低抗体合成。但多数喷鼻药物由于鼻腔黏液纤毛传输系统的作用而无法长期停留在鼻腔鼻窦黏膜,从而降低了药物的疗效,且药物疗效依赖于患者对治疗的依从性。因此,临床上需要一种能够广泛应用的,较长期稳定持续释放糖皮质激素激素,良好止血效果且容易塑形预防鼻窦粘连和不阻碍鼻窦引流的生物合成材料。
发明内容
本发明的目的之一在于提供一种载布地纳德壳聚糖海绵。
本发明的目的之二在于提供上述海绵的制备方法。
本发明的目的之三在于提供上述海绵的用途。
具体技术方案如下:
本发明提供了一种载布地纳德壳聚糖海绵,所述海绵包括布地纳德、壳聚糖。
优选地,布地纳德与壳聚糖的质量比是1:10。
进一步,所述海绵还可包括交联剂;优选地,布地纳德、壳聚糖与交联剂的质量比是2:20:1。
可用于本发明的交联剂包括京尼平、甲醛、戊二醛、EDC、原花青素。在本发明的具体实施方案中,所述交联剂是京尼平。
进一步,所述海绵还可包括非离子表面活性剂;优选地,布地纳德、壳聚糖与非离子表面活性剂的质量比是1:10:1。
可用于本发明的非离子表面活性剂包括Pluronic F68、F108、F127。在本发明的具体实施方案中,所述非离子表面活性剂是F127。
进一步,所述海绵还可包括塑性剂;优选地,布地纳德、壳聚糖与塑性剂的质量比是1:10:5。
可用于本发明的所述塑性剂包括甘油、聚乙二醇、丙三醇。在本发明的具体实施方案中,所述塑性剂甘油。
本发明还提供了前面所述海绵的制备方法,所述制备方法包括如下步骤:
(1)布地纳德溶解加入非离子表面活性剂搅拌形成溶液A;
(2)壳聚糖溶解配制成溶液B;
(3)溶液B中加入溶液A、塑性剂、交联剂搅拌配制成溶液C;
(4)将步骤(3)获得的溶液C倒入模具中冻干保存。
优选地,所述非离子表面活性剂包括Pluronic F68、F108、F127。
优选地,所述塑性剂包括甘油、聚乙二醇、丙三醇。
优选地,所述交联剂包括京尼平、甲醛、戊二醛、EDC、原花青素。
优选地,溶液A中,布地纳德与非离子表面活性剂的质量比是1:1。
优选地,溶液C中,布地纳德与壳聚糖的质量比是1:10。
优选地,溶液C中,塑性剂与交联剂的质量比是10:1。
优选地,溶液C中,布地纳德、壳聚糖与交联剂的质量比是2:20:1。
优选地,溶液C中,布地纳德、壳聚糖与塑性剂的质量比是1:10:5。
在本发明的具体实施方案中,所述制备方法包括如下步骤:
将1g布地纳德喷剂用蒸馏水稀释至20mL,加入1g F127搅拌至溶解,配置成溶液A。将10g壳聚糖溶于400mL蒸馏水(1%醋酸)中,配制成溶液B,再加入5g甘油、0.5g京尼平,及溶液A,继续搅拌60分钟。将上述溶液倒入硅胶模具中,冻干保存。
本发明还提供了前面所述的海绵在制备止血抗炎的辅料中的应用。
本发明的优点和有益效果:
本发明制备的载药海绵产具有吸水迅速、吸水能力强等特点,能够迅速吸收伤口表面的血液。一方面,壳聚糖具有促进血液凝固(壳聚糖表面具有大量的氨基基团,带正电的氨基基团与带负电的红细胞作用,使红细胞粘附聚集,从而使血液凝聚)、灭菌、促进伤口愈合、吸收伤口渗出物、不易脱水收缩等作用,另一方面,负载的药物具有止血、凝血、消炎等作用。所以,通过将壳聚糖和药物相配合,协同作用能够迅速吸收伤口表面的血液,有效促进创面凝血,实现快速止血的目的。
根据受伤部位、伤口形状的不同,可以将本发明制备的载药止血海绵放入不同形状的模具中进行压制成型处理,压制后进行真空包装,进而得到特定形状的压缩载药止血海绵,以满足不同伤口的止血需求,同时压制处理后的压缩载药止血海绵便于储存、运输和携带。
本发明海绵材料质地轻而柔软,富有弹性,不会对伤口产生刺激和摩擦。
本发明的制备方法操作简便,且全程反应条件温和,所制的复合海绵为多孔结构,机械性能、凝血性能与液体吸收能力好。壳聚糖的制备及海绵的制备过程周期较短,效率高,因而使得规模化生产成为可能。
本发明所制得的海绵可任意折叠,止血效果显著。
本发明所制得的海绵不沾粘伤口,可防止伤口感染,促进愈合。
本发明制备的壳聚糖多孔海绵孔径分布均匀,大约在200μm左右。通过结合冷冻干燥技术和运用表面活性剂与多糖的高速搅拌制备多孔材料,不仅产品结构均匀,孔隙率高,更增强了其机械强度,有利于加速止血,术腔填塞时可降解并缓释布地奈德抗炎作用。
附图说明
图1显示本发明的海绵的扫描电镜图;
图2显示DIP内镜评分总分及水肿/息肉评分统计图。
具体实施方式
下面结合附图和实施例对本申请进行进一步的介绍。
实施例1载布地纳德壳聚糖海绵制备及性能检测
1、制备方法
将1g布地纳德喷剂用蒸馏水稀释至20mL,加入1g F127搅拌至溶解,配置成溶液A。将10g壳聚糖溶于400mL蒸馏水(1%醋酸)中,配制成溶液B,再加入5g甘油、0.5g京尼平,及溶液A,继续搅拌60分钟。将上述溶液倒入硅胶模具中,冻干保存。
2、扫描电镜观察
用S-4800(日本Hitachi公司)扫描电子显微镜来观察壳聚糖止血海绵的微观结构。所有样品先经过60℃、真空条件下充分干燥,观测前喷金处理。通过电镜观察可以看出,制备得到的壳聚糖多孔海绵孔径分布均匀,大约在200μm左右。通过结合冷冻干燥技术和运用表面活性剂与多糖的高速搅拌制备多孔材料,不仅产品结构均匀,孔隙率高,更增强了其机械强度,有利于加速止血,扫描电镜图片见图1。
实施例2载布地奈德壳聚糖海绵的临床应用
1资料与方法
1.1临床资料
本研究采用双盲、前瞻性试验设计,以2019年7月-2019年12月宁波大学医学院附属医院耳鼻喉科收治实施ESS的CRS患者为研究对象。此研究方案已获得宁波大学医学院伦理委员会同意并备案。所有患者签署知情同意书。CRS诊断标准参考《中国慢性鼻窦炎诊断和治疗指南(2018)》。本组资料共纳入49例,其中男性30例、女性19例,年龄16-65岁。
1.2治疗方案
术前所有患者均进行鼻窦CT扫描及鼻内镜检查,术前1周口服抗生素及布地奈德喷鼻剂喷鼻,一天两次治疗。所有患者在全身麻醉下行ESS,术后根据按随机数字表法术腔分别填塞载药绵(载布地奈德壳聚糖海绵)组25例,填塞纳吸绵(Nasopore,荷兰PolyganicsBV公司)组24例,并继续以抗生素治疗1周。所有患者术后第8天用起生理盐水冲洗鼻腔内分泌物,术后2周鼻内镜下清理鼻腔鼻窦,清理后继续使用布地奈德鼻喷剂喷鼻治疗,一天两次,每次每鼻孔喷2揿。记录术后2周、4周内镜评分结果。
1.3评估方法
分别于治疗前1天、治疗后2周、4周采用分泌物、炎症及息肉/水肿(Discharge,Inflammation,Polyps/Edema,DIP)内镜评分系统评分。DIP内镜评分是根据分泌物、炎症、息肉或水肿等3个项目进行评分,每个项目计0~10分,分泌物:0分代表“无分泌物”,5分代表“黏稠分泌物”,10分代表“脓性分泌物”;炎症:0分代表“无炎症”,5分代表“中度炎症”,10分代表“重度炎症”;息肉或水肿:0分代表“无息肉或水肿”,5分代表“明显水肿但无息肉”,10分代表“多个息肉充满鼻腔”。手术后第1天分别对鼻阻、流涕及疼痛等症状进行视觉模拟量表评分(visual analogue scales,VAS)评分。按照VAS评分将病情分为:轻度0-3分;中度>3-7分;重度>7-10分;若VAS>5分,则表示患者生活质量受到影响。
1.4统计学分析
采用SPSS 20.0统计学软件处理数据,计量资料以均数±标准差表示。对于定量资料,用t检验和非参数检验分别评价正态分布数据和非正态分布数据两组间的差异;计数资料采用χ2检验。以P<0.05为差异有统计学意义。
2、结果
两组患者一般情况差异无统计学意义,手术后1天两组鼻面胀痛、流泪等VAS评分差异无统计学意义(P>0.05)(表1);载药绵填塞组术后4周DIP内镜评分总分及息肉/水肿、炎症等评分显著优于术后2周,鼻腔分泌物评分差异无统计学意义;而纳吸绵组术后4周DIP内镜评分相较于术后2周均无显著性差异。载药绵填塞组术后2周DIP内镜评分相较于纳吸绵填塞组无显著性差异,术后4周DIP内镜评分总分及水肿/息肉评分显著优于纳吸绵填塞组(图2,*P<0.05相较于载药绵;##P<0.01相较于术后周;.n.s.代表无显著性差异)。所有患者术后2周、4周均无鼻腔鼻窦粘连,2例患者术后鼻腔轻微活动性出血,加压后血止。故术后粘连、出血等情况未予以统计分析。
组别 | 例数(男:女) | 年龄(岁) | VAS总分 |
载布地奈德壳聚糖海绵 | 25(16:9) | 43.08±15.96 | 6.08+2.11 |
纳吸绵 | 24(13:11) | 42.17±15.61 | 5.67+2.35 |
P值 | 0.5926 | 0.8410 | 0.5232 |
应当说明的是,上述实施例均可根据需要自由组合。以上介绍仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种载布地纳德壳聚糖海绵,其特征在于,所述海绵包括布地纳德、壳聚糖;优选地,布地纳德与壳聚糖的质量比是1:10。
2.根据权利要求1所述的海绵,其特征在于,所述海绵还包括交联剂;优选地,布地纳德、壳聚糖与交联剂的质量比是2:20:1。
3.根据权利要求2所述的海绵,其特征在于,所述交联剂包括京尼平、甲醛、戊二醛、EDC、原花青素。
4.根据权利要求1所述的海绵,其特征在于,所述海绵还包括非离子表面活性剂;优选地,布地纳德、壳聚糖与非离子表面活性剂的质量比是1:10:1。
5.根据权利要求4所述的海绵,其特征在于,所述非离子表面活性剂包括PluronicF68、F108、F127。
6.根据权利要求1所述的海绵,其特征在于,所述海绵还包括塑性剂;优选地,布地纳德、壳聚糖与塑性剂的质量比是1:10:5。
7.根据权利要求6所述的海绵,其特征在于,所述塑性剂包括甘油、聚乙二醇、丙三醇。
8.权利要求1-7中任一项所述海绵的制备方法,其特征在于,所述制备方法包括如下步骤:
(1)布地纳德溶解加入非离子表面活性剂搅拌形成溶液A;
(2)壳聚糖溶解配制成溶液B;
(3)溶液B中加入溶液A、塑性剂、交联剂搅拌配制成溶液C;
(4)将步骤(3)获得的溶液C倒入模具中冻干保存;
优选地,所述非离子表面活性剂包括Pluronic F68、F108、F127;
优选地,所述塑性剂包括甘油、聚乙二醇、丙三醇;
优选地,所述交联剂包括京尼平、甲醛、戊二醛、EDC、原花青素;
优选地,溶液A中,布地纳德与非离子表面活性剂的质量比是1:1;
优选地,溶液C中,布地纳德与壳聚糖的质量比是1:10;
优选地,溶液C中,塑性剂与交联剂的质量比是10:1;
优选地,溶液C中,布地纳德、壳聚糖与交联剂的质量比是2:20:1;
优选地,溶液C中,布地纳德、壳聚糖与塑性剂的质量比是1:10:5。
9.根据权利要求8所述的制备方法,其特征在于,所述制备方法包括如下步骤:
将1g布地纳德喷剂用蒸馏水稀释至20mL,加入1g F127搅拌至溶解,配置成溶液A。将10g壳聚糖溶于400mL蒸馏水(1%醋酸)中,配制成溶液B,再加入5g甘油、0.5g京尼平,及溶液A,继续搅拌60分钟。将上述溶液倒入硅胶模具中,冻干保存。
10.权利要求1-7中任一项所述的海绵在制备止血抗炎的辅料中的应用。
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