CN111184911A - 一种口腔止血及修复材料及其制备方法 - Google Patents
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Abstract
本发明提供一种口腔止血及修复材料,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒30~50份、羧甲基壳聚糖10~20份、维生素E醋酸酯20~60份。本发明所述的口腔止血及修复材料中脱钙骨颗粒作为口腔止血及修复材料的载体,其所含有的胶原结构对创面骨质的矿物沉积具有诱导作用,与生长因子及其它植骨材料结合,可有效地引发和控制矿化过程,促进新骨的形成,从而提高本发明中口腔止血及修复材料对拔牙后缺损部位处诱导新骨的再生的作用。
Description
技术领域
本发明属于生物医用材料领域,具体涉及一种口腔止血及修复材料及其制备方法。
背景技术
拔牙后出血是常见的牙拔除术后并发症,发生率在0 ~ 26%之间,大多由局部因素引起,如不及时处理,可导致严重的并发症。合理的选择及应用局部止血材料覆盖和(或)充填拔牙窝是治疗及预防拔牙后出血的重要措施。拔牙窝由于其特殊的解剖特点(拔牙窝由固有牙槽骨包绕形成骨壁),直接对拔牙窝进行加压处理和(或)使用止血材料充填和(或)覆盖拔牙窝是最有效的预防及处理拔牙后出血的方法。临床上针对拔牙后出血常用方法如下:(1)针对常规拔牙窝,直接将棉条或纱布置于拔牙创表面后咬紧压迫止血即可;(2)针对切开翻瓣或软组织撕裂伤的拔牙窝,可缝合创口后局部使用棉条或纱布加压;(3)针对因使用抗凝剂而具有轻度出血倾向的患者可在拔牙窝内充填止血材料或使用覆盖材料封闭拔牙窝,即可达到加速凝血、稳定血凝块、保护拔牙创的目的;(4)针对患有血友病等明显凝血功能障碍患者,为避免因缝合导致的针眼渗血,可在拔牙窝内充填止血材料后再使用覆盖材料封闭拔牙创;(5)针对患有严重凝血功能障碍的患者,应使用止血材料充填拔牙窝,覆盖材料封闭拔牙创,再对拔牙窝进行外加压,才能达到止 血的目的。随着材料科学的发展,目前应用于处理及预防拔牙后出血材料较多,经将该类材料覆盖及充填拔牙窝后均有一定的止血效果。
专利201320182087.X公开了一种牙科术后止血球,该止血球内核采用卫生脱脂棉球,卫生脱脂棉球的外围包裹有明胶海绵,明胶海绵外围包裹有纱布包,纱布包上开设有网孔,纱布包裹紧明胶海绵,将明胶海绵的外层部分挤出网孔外呈椭球球冠状。该止血球整体呈椭球形。该牙科术后止血球应用在牙科术后对牙床、牙龈部进行快速止血,其能在拔牙后对患者口腔内的创伤部迅速止血,节省术者操作时间。该专利中的止血球可快速止血,但因无法术后降解吸收,术后缺损部位修复后难以取出材料或取出时造成二次损伤;
专利201110173291.0公开了一种胶原蛋白-PCL牙科止血海绵及其制备方法,其主要通过胶原蛋白溶液、PCL溶液和辅助添加剂共混后,经冷冻干燥制备得到胶原蛋白-PCL止血海绵。该发明制备的胶原蛋白-PCL止血海绵具有一定的固位性、止血性、抗炎抑菌性和生物相容性。该专利中材料术后止血行有待提高,同时因材料吸血后可能存在皱缩变形,对于术后缺损部位固位效果仍需提高;
专利201110361186.X公开了一种胶原蛋白海绵的制备工艺,其主要以新鲜猪皮为原料,经预处理、去除脂肪、经酸酶法处理、超声波处理、纯化、酶法交联和冷冻干燥制得胶原蛋白海绵。该发明胶原蛋白海绵的制备方法提取效率高,产品纯度达到98%以上。该产品包含保持三螺旋结构的活性胶原冷冻干燥制成胶原蛋白海绵,具有低免疫原性、高生物相容性,可生物降解,适用于医疗用途。该材料具有低免疫原性、高生物相容性,可生物降解,但对于拔牙窝术后止血后并不具有损伤部位修复功效。
发明内容
针对现有技术的不足,本发明提供一种止血性能强、可促进拔牙窝术后创面愈合、且可塑型使用的可降解吸收口腔止血及修复材料及其制备方法。
本发明的目的是通过以下技术方案来实现的:
提供一种口腔止血及修复材料,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒30~50份、羧甲基壳聚糖10~20份、维生素E醋酸酯20~60份。
优选地,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒30~40份、羧甲基壳聚糖10~15份、维生素E醋酸酯20~40份。
优选地,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒40~50份、羧甲基壳聚糖15~20份、维生素E醋酸酯40~60份。
优选地,所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2 小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6 mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
另一方面,提供上述的口腔止血及修复材料的制备方法,包括以下步骤:
1)将40份维生素E醋酸酯于70℃加热后,将20份羧甲基纤维素钠加入热的维生素E醋酸酯中混合均匀,然后于室温冷却后得到止血胶泥;
2)将40份脱钙骨颗粒加入上述止血胶泥,共混胶合后,再经塑型、包装、灭菌后得到具有多孔结构、可塑型,且可降解吸收的口腔止血和修复材料。
优选地,所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2 小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6 mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
相对于现有技术,本发明优选实施例的有益效果在于:
羧甲基壳聚糖,属于可吸收聚合物材料,羧甲基壳聚糖的加入,可有效吸附血液中多余水分抑制血液的流动性,同时能够激发生理止血机制,起到物理止血和生理止血效用,因此壳聚糖衍生物的加入能有效提高口腔止血及修复材料的止血性能。
本发明所述的口腔止血及修复材料中脱钙骨颗粒作为口腔止血及修复材料的载体,其所含有的胶原结构对创面骨质的矿物沉积具有诱导作用,与生长因子及其它植骨材料结合,可有效地引发和控制矿化过程,促进新骨的形成,从而提高本发明中口腔止血及修复材料对拔牙后缺损部位处诱导新骨的再生的作用。止血胶泥可有效吸附血液中多余水分抑制血液的流动性,能够激发生理止血机制,起到物理止血和生理止血效用,同时止血胶泥作为基质材料,与脱钙骨颗粒胶合后可实现塑型的效果,从而便于临床使用。
综上所述,本发明提供的口腔止血及修复材料具有较好的止血性能,具有较佳的可塑型性,并且可于体内降解吸收,无免疫原性,安全性高,在促进拔牙后口腔止血和缺损部位骨愈合方面较佳的实施效果。
附图说明
图1 犬拔牙窝缺损模型实验组术后8周取材观察图;
图2 犬拔牙窝缺损模型空白对照组术后8周取材观察图;
图3 犬拔牙窝缺损模型实验组术后8周MicroCT观察图;
图4 犬拔牙窝缺损模型对照组术后8周MicroCT观察图。
具体实施例
下面通过具体实施方式来进一步说明本发明的技术方案。本领域技术人员应该明了,所述实施例仅仅是帮助理解本发明,不应视为对本发明的具体限制。
实施例1
本发明提供一种口腔止血及修复材料,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒40份、羧甲基壳聚糖20份、维生素E醋酸酯40份。
在一些实施例中,所述脱钙骨颗粒的重量份数为30份、31份、32份、33份、34份、35份、36份、37份、38份、39份、41份、42份、43份、44份、45份、46份、47份、48份、49份或50份;所述羧甲基壳聚糖的重量份数为10份、11份、12份、13份、14份、15份、16份、17份、18份、19份或20份;所述维生素E醋酸酯的重量份数为20份、21份、22份、23份、24份、25份、26份、27份、28份、29份、30份、31份、32份、33份、34份、35份、36份、37份、38份、39份、40份、41份、42份、43份、44份、45份、46份、47份、48份、49份、50份、51份、52份、53份、54份、55份、56份、57份、58份、59份或60份。
本实施例所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2 小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6 mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
实施例2
本实施例提供实施例1所述的口腔止血及修复材料的制备方法,包括以下步骤:
1)将40份维生素E醋酸酯于70℃加热后,将20份羧甲基纤维素钠加入热的维生素E醋酸酯中混合均匀,然后于室温冷却后得到止血胶泥;
2)将40份脱钙骨颗粒加入上述止血胶泥,共混胶合后,再经塑型、包装、灭菌后得到具有多孔结构、可塑型,且可降解吸收的口腔止血和修复材料。
所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2 小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6 mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
效果验证:犬拔牙窝止血试验
采用3%戊巴比妥钠按照1ml/kg体重静脉麻醉,分别拔除下颌两侧第2、3、4前磨牙。扩骨使得各牙窝缺损一致:顶部颊舌向5mm,顶部近远中向5mm,深度11mm(偏差0.5mm),所有牙槽窝位点均用刮匙搔刮至净。下颌骨右侧作为实验侧,下颌骨左侧为对照组,实验组植入实施例1所述口腔止血及修复材料止血,对照组采用纱布止血,观察5min内拔牙部位渗出血情况,记录材料使用情况,待观察结束后直接缝合,于术后8w取材观察、评价。
1)术中观察
实验组材料填塞1块材料后5min内未出现渗出血,对照组填塞并替换3块止血纱布后,咬合止血,5min内未出现渗出血。
2)术后观察
图1、图2分别为实验组、对照组的犬拔牙窝缺损处8周取材观察结果,实验组和对照组缺损表面已大部分修复。图3、图4为犬拔牙窝缺损处8周MicroCT观察结果,实验组和对照组BV/TV(骨体积分数)分别为47.92%和40.09%。根据8w取材部位MicroCT结果可知,实验组较对照组缺损部位修复较为明显。
表2 犬拔牙窝缺损模型术后8w取材部位
试验组 | BV/TV/% |
对照组 | 40.09±4.44 |
实验组 | 47.92±2.18 |
尽管以上结合附图对本发明的实施方案进行了描述,但是本发明并不局限于上述的具体实施方案和应用领域,上述的具体实施方案仅仅是示意性的、指导性的,而不是限制性的。本领域的普通技术人员在说明书的启示下,在不脱离本发明权利要求所保护的范围的情况下, 所做的无需创造性劳动的改进和替换都将落入本发明的保护范围。
Claims (6)
1.一种口腔止血及修复材料,其特征在于,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒30~50份、羧甲基壳聚糖10~20份、维生素E醋酸酯20~60份。
2.根据权利要求1所述的口腔止血及修复材料,其特征在于,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒30~40份、羧甲基壳聚糖10~15份、维生素E醋酸酯20~40份。
3.根据权利要求1所述的口腔止血及修复材料,其特征在于,按照重量份数计,所述口腔止血及修复材料由以下组分制备而成:脱钙骨颗粒40~50份、羧甲基壳聚糖15~20份、维生素E醋酸酯40~60份。
4.根据权利要求1所述的口腔止血及修复材料,其特征在于,所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
5.权利要求1-4任一项所述的口腔止血及修复材料的制备方法,其特征在于,包括以下步骤:
1)将40份维生素E醋酸酯于70℃加热后,将20份羧甲基纤维素钠加入热的维生素E醋酸酯中混合均匀,然后于室温冷却后得到止血胶泥;
2)将40份脱钙骨颗粒加入上述止血胶泥,共混胶合后,再经塑型、包装、灭菌后得到具有多孔结构、可塑型,且可降解吸收的口腔止血和修复材料。
6.根据权利要求5所述的制备方法,其特征在于,所述脱钙骨颗粒由以下方法制备而成:将牛股骨经粉碎制成粒径不大于600 μm的天然骨粉末,采用纯化水经超声波清洗3次,每次10 分钟;然后将清洗后的天然骨粉末依次采用3倍重量份的无水乙醇浸泡2 小时、1倍重量份的乙醚浸泡2小时、5倍重量份的纯化水冲洗5次;用3倍重量份的浓度为0.6 mol/L的盐酸水溶液脱钙处理24小时后,采用5倍重量份的纯化水再次清洗3次,常温通风干燥12小时后即制备得到脱钙骨颗粒。
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