CN112790994A - 一种基于聚（4-羟基丁酸酯）根管填充材料及其制备方法 - Google Patents
一种基于聚（4-羟基丁酸酯）根管填充材料及其制备方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
- A61K6/884—Preparations for artificial teeth, for filling teeth or for capping teeth comprising natural or synthetic resins
- A61K6/891—Compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/50—Preparations specially adapted for dental root treatment
- A61K6/54—Filling; Sealing
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/70—Preparations for dentistry comprising inorganic additives
- A61K6/71—Fillers
- A61K6/74—Fillers comprising phosphorus-containing compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/70—Preparations for dentistry comprising inorganic additives
- A61K6/71—Fillers
- A61K6/74—Fillers comprising phosphorus-containing compounds
- A61K6/75—Apatite
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
- A61K6/802—Preparations for artificial teeth, for filling teeth or for capping teeth comprising ceramics
- A61K6/818—Preparations for artificial teeth, for filling teeth or for capping teeth comprising ceramics comprising zirconium oxide
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Abstract
本发明公开一种基于聚(4‑羟基丁酸酯)根管填充材料及其制备方法。本发明以聚(4‑羟基丁酸酯)为主相，并加入至少一种表面接枝聚(4‑羟基丁酸酯)的无机填料、至少一种对X射线具有阻射作用的化合物和至少一种塑化剂。将上述材料在熔融状态下进行熔融共混制得本发明的根管填充材料。本发明所制备新型树脂填充材料具有优异的生物相容性、稳定性、粘结性和抗渗漏性，为根管治疗填充材料提供了新的选择。
Description
技术领域
本发明涉及口腔材料领域，具体涉及一种基于聚(4-羟基丁酸酯)根管填充材料及其制备方法。
背景技术
根管治疗又称牙髓治疗术，是治疗牙髓病和根尖周病的最佳治疗方法。近些年来根管治疗技术有了显著的提高，但其重要组成部分根管填充材料没有显著的改变。目前，基于高分子材料的固体根管填充物包括：以天然杜仲橡胶即反式-1,4-聚异戊二烯为主相的牙胶填充材料、热塑性共聚改性聚合物或接枝改性聚合物材料(CN 101416923 B)和基于聚己内酯为主相的可降解树脂填充材料Resilon产品(US20030113686A1)。自2003年Resilon树脂根管填充材料研发以来，尚未有新型根管填充高分子材料问世。
聚(4-羟基丁酸酯)是美国食品药物管理局(U.S.Food and DrugAdministration，U.S.FDA)批准的一种生物可降解医用高分子聚酯，其已在手术缝合线和疝气补片等领域获得应用。聚(4-羟基丁酸酯)特殊的五元含氧杂环分子结构使其比聚己内酯具有更高的极性、更优异的生物相容性、更好的根管封闭效果和更低的微渗漏率，可大大提高根管治疗的成功率。因此，研发一类新型聚(4-羟基丁酸酯)根管填充材料，在基础研究和临床应用等方面均具有重要的价值。
发明内容
本发明的目的是为根管治疗提供更佳的填充材料选择，提供一种基于聚(4-羟基丁酸酯)根管填充材料及其制备方法，本发明制备的根管填充材料具有更优异生物相容性、稳定性、粘结性和抗渗漏性。
本发明提供的一种基于聚(4-羟基丁酸酯)根管填充材料及其制备方法，通过以下技术方案得以实现：
将聚(4-羟基丁酸酯)、表面接枝聚(4-羟基丁酸酯)的无机填料、对X射线具有阻射作用的化合物和塑化剂混合均匀后，在70–150℃熔融状态下，熔融共混5-20分钟，制得本发明的根管填充材料。
本发明采用混合物配比(质量分数)：
所述的聚(4-羟基丁酸酯)重均分子量为10000-200000。
所述的表面接枝聚(4-羟基丁酸酯)的无机填料为表面接枝聚(4-羟基丁酸酯)的羟基磷灰石、表面接枝聚(4-羟基丁酸酯)的氧化锌、表面接枝聚(4-羟基丁酸酯)的磷酸三钙、表面接枝聚(4-羟基丁酸酯)的生物玻璃、表面接枝聚(4-羟基丁酸酯)的氧化镁和表面接枝聚(4-羟基丁酸酯)的白炭黑的一种或几种。
所述的对X射线具有阻射功能的化合物为钛酸钡、钛酸铋、锆酸钡、钨酸钙、硫酸钡、氧化锆、氧化铋、氯化氧铋、氧化钽中的一种或几种。
所述的塑化剂为聚醚多元醇。
所述的熔融共混是在单螺杆挤出机、双螺杆挤出机或密炼机中的一种中进行。
与现有技术相比，本发明的有益效果是：
本发明制备的新型基于聚(4-羟基丁酸酯)根管填充材料具有比Resilon树脂填充材料更好的生物学相容性、稳定性、粘结性和抗渗漏性。采用Epiphany封闭剂，对离体牙填充基于聚(4-羟基丁酸酯)根管填充材料，在完全固化后测定其粘结强度，基于聚(4-羟基丁酸酯)根管填充材料粘结强度可达到2.01MPa，高于Resilon树脂填充材料的1.50MPa；在第30天的细菌微渗漏量为3.85mM/L，少于Resilon树脂填充材料的4.5mM/L。
具体实施方式
以下通过具体实施方式对本发明作进一步的详细说明，但不应将此理解为本发明的范围仅限于以下的实例。在不脱离本发明上述方法思想的情况下，根据本领域普通技术知识和惯用手段做出的各种替换或变更，均应包含在本发明的范围内。
实施例1
将上述物料混合均匀并在密炼机中100℃条件下熔融共混10分钟，获得根管填充材料。采用Epiphany封闭剂，对离体牙填充基于聚(4-羟基丁酸酯)根管填充材料，在完全固化后测定其粘结强度，其粘结强度可达到1.96MPa；30天的细菌微渗漏量为4.15mM/L。本发明制备根管填充材料相比Resilon树脂填充材料具有更好的稳定性、粘结性和抗渗漏性。
实施例2
将上述物料混合均匀并在密炼机中120℃条件下熔融共混15分钟，获得根管填充材料。采用Epiphany封闭剂，对离体牙填充基于聚(4-羟基丁酸酯)根管填充材料，在完全固化后测定其粘结强度，其粘结强度可达到1.86MPa；30天的细菌微渗漏量为3.96mM/L。本发明制备根管填充材料相比Resilon树脂填充材料具有更好的稳定性、粘结性和抗渗漏性。
实施例3
将上述物料混合均匀并在密炼机中80℃条件下熔融共混8分钟，获得根管填充材料。采用Epiphany封闭剂，对离体牙填充基于聚(4-羟基丁酸酯)根管填充材料，在完全固化后测定其粘结强度，其粘结强度可达到1.80MPa；30天的细菌微渗漏率为。本发明制备根管填充材料相比Resilon树脂填充材料具有更好的稳定性、粘结性和抗渗漏性。
Claims (9)
1.一种基于聚(4-羟基丁酸酯)根管填充材料及其制备方法，其中，根管填充材料主相为生物可降解热塑性聚酯-聚(4-羟基丁酸酯)，其在混合物中的质量分数范围为50–100wt％。
2.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中聚(4-羟基丁酸酯)重均分子量为10000-100000。
3.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中，还包含表面接枝聚(4-羟基丁酸酯)的无机填料，其在混合物中的质量分数最高为50wt％。
4.根据权利要求3所述的聚(4-羟基丁酸酯)根管填充材料，其中，所述表面接枝聚(4-羟基丁酸酯)的无机填料包括表面接枝聚(4-羟基丁酸酯)的羟基磷灰石、表面接枝聚(4-羟基丁酸酯)的氧化锌、表面接枝聚(4-羟基丁酸酯)的磷酸三钙、表面接枝聚(4-羟基丁酸酯)的生物玻璃、表面接枝聚(4-羟基丁酸酯)的氧化镁和表面接枝聚(4-羟基丁酸酯)的白炭黑的一种或几种。
5.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中，还包含对X射线具有阻射作用的化合物：钛酸钡、钛酸铋、锆酸钡、钨酸钙、硫酸钡、氧化锆、氧化铋、氯化氧铋、氧化钽中的一种或几种。
6.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中，还包含塑化剂，其在混合物中的质量分数范围为10–40wt％。
7.根据权利要求6所述的聚(4-羟基丁酸酯)根管填充材料，其中，塑化剂为聚醚多元醇。
8.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中，熔融共混仪器可以是单螺杆挤出机、双螺杆挤出机、密炼机中的任意一种。
9.根据权利要求1所述的聚(4-羟基丁酸酯)根管填充材料，其中，熔融共混温度为70-150℃，熔融共混时间为5-20分钟。
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| US20030124483A1 (en) * | 2001-10-24 | 2003-07-03 | Weitao Jia | Dental filling material |
| US20060257448A1 (en) * | 2005-05-10 | 2006-11-16 | The University Of Zurich | Resorbable polymer composition, implant and method of making implant |
| CN101416923A (zh) * | 2008-12-05 | 2009-04-29 | 中山大学附属口腔医院 | 一种根管充填材料的制备方法 |
| EA201100986A1 (ru) * | 2010-07-21 | 2012-02-28 | Федеральное Государственное Автономное Образовательное Учреждение Высшего Профессионального Образования "Сибирский Федеральный Университет" | Хирургический материал для реконструкции дефектов костной ткани (варианты) |
| CN103110979A (zh) * | 2013-02-09 | 2013-05-22 | 复旦大学 | 表面沉积类骨磷灰石的高分子多孔材料及其制备方法和应用 |
| CN103610599A (zh) * | 2013-10-21 | 2014-03-05 | 北京化工大学 | 一种具有x-射线阻射性齿科修复树脂及其制备方法 |
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| US20030124483A1 (en) * | 2001-10-24 | 2003-07-03 | Weitao Jia | Dental filling material |
| US20060257448A1 (en) * | 2005-05-10 | 2006-11-16 | The University Of Zurich | Resorbable polymer composition, implant and method of making implant |
| CN101416923A (zh) * | 2008-12-05 | 2009-04-29 | 中山大学附属口腔医院 | 一种根管充填材料的制备方法 |
| EA201100986A1 (ru) * | 2010-07-21 | 2012-02-28 | Федеральное Государственное Автономное Образовательное Учреждение Высшего Профессионального Образования "Сибирский Федеральный Университет" | Хирургический материал для реконструкции дефектов костной ткани (варианты) |
| CN103110979A (zh) * | 2013-02-09 | 2013-05-22 | 复旦大学 | 表面沉积类骨磷灰石的高分子多孔材料及其制备方法和应用 |
| CN103610599A (zh) * | 2013-10-21 | 2014-03-05 | 北京化工大学 | 一种具有x-射线阻射性齿科修复树脂及其制备方法 |
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