CN112220974A - 基于3d打印的丹参酮ⅱa血管支架的制备方法 - Google Patents

基于3d打印的丹参酮ⅱa血管支架的制备方法 Download PDF

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CN112220974A
CN112220974A CN202011187073.8A CN202011187073A CN112220974A CN 112220974 A CN112220974 A CN 112220974A CN 202011187073 A CN202011187073 A CN 202011187073A CN 112220974 A CN112220974 A CN 112220974A
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陶玲
沈祥春
蒋丹
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Abstract

本发明公开了基于3D打印的丹参酮ⅡA血管支架的制备方法,包括以下步骤：a、建模：设计血管支架的3D模型，得建模数据；b、制备打印溶液：称取丹参酮IIA原料药，加乙醇，在超声仪中溶解，得溶液A；另称取聚乳酸，与溶液A混合，并加入二氯甲烷溶解，得溶液B；c、3D打印血管支架：将建模数据输入3D打印机的程序中，将溶液B装入3D打印针筒，制备与血管内径大小一致的圆筒，转动圆筒，从3D打印针筒内挤出溶液B，打印到圆筒表面，得血管支架样品；d、将血管支架样品烘干、冷却后，得血管支架成品。本发明既具有减少血管再狭窄、血栓形成、血管壁损概率的特点，又具有载药量高、药物有效均匀分布、释放时间长的特点。

Description

基于3D打印的丹参酮ⅡA血管支架的制备方法
技术领域
本发明涉及一种医用器械制备领域，特别是一种基于3D打印的丹参酮ⅡA血管支架的制备方法。
背景技术
近年来，随着人们生活水平的不断提高，心血管疾病已经成为人类健康的重大威胁，是导致人类死亡和致残的重要因素之一。随着血管内治疗技术的发展，血管内支架植入术已经成为了治疗心血管疾病最有效的方法之一。血管支架是指在管腔球囊扩张成形的基础上，在病变段置入内支架以达到支撑狭窄闭塞段血管，减少血管弹性回缩及再塑形，保持管腔血流通畅的目的。
丹参酮ⅡA(Manshinone IIA，TA)是唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根及根茎中提取的脂溶性菲醌化合物，历史悠久，疗效显著，在我国临床用于扩张冠脉、扩张血管、抗血栓、改善微循环障碍、保护血管内皮细胞损伤等，但水溶性差，释放极为缓慢。
目前3D打印技术在国际上已开始被应用于器官模型的制造与手术分析策划、个性化组织工程支架材料和假体植入物的制造等方面，利用3D打印技术可以根据不同患者的CT、磁共振成像(MRI)等成像数据，快速制造个性化的组织工程支架材料，从而实现材料与患者病变部位的完美匹配。但是对于血管支架而言，材料要求和尺寸精度要求比较高，其中3D打印的PLA支架和金属支架应用临床治疗后，容易对机体造成二次刺激，带来不同程度的血小板聚集、新的血栓的形成、短期内引发血管壁再狭窄、造成血管壁损等问题；而在支架表面涂以肝素、氧化钛等物质，或覆以可降解或不可降解的聚合物薄膜，或涂抹或者添加抗凝血药物的覆膜支架，存在载药量低、不够均匀、涂抹的药物释放过快的问题。
因此，现有的3D打印成型的PLA血管支架或者金属血管支架，存在容易造成血管再狭窄、血栓形成、血管壁损的问题，在支架表面涂覆药物的方式，存在载药量低且不均匀、药物释放过快的问题。
发明内容
本发明的目的在于，提供一种基于3D打印的丹参酮ⅡA血管支架的制备方法。本发明既具有减少血管再狭窄、血栓形成、血管壁损概率的特点，又具有载药量高、药物有效均匀分布、释放时间长的特点。
本发明的技术方案：基于3D打印的丹参酮ⅡA血管支架的制备方法，包括以下步骤：
a、建模：用计算机建模软件设计血管支架的3D模型，得建模数据；
b、制备打印溶液：称取丹参酮IIA原料药400-1000mg，加5-20mL乙醇，在超声仪中溶解20-40min，得溶液A；另称取聚乳酸2-10g，与溶液A混合，并加入二氯甲烷30-80ml溶解，得溶液B；
c、3D打印血管支架：将建模数据输入3D打印机的程序中，将溶液B装入3D打印针筒，制备与血管内径大小一致的圆筒，转动圆筒，从3D打印针筒内挤出溶液B，打印到圆筒表面，得血管支架样品；
d、将血管支架样品经过烘干、冷却后，得血管支架成品。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤b为，制备打印溶液：称取丹参酮IIA原料药450-550mg，加8-15mL乙醇，在超声仪中溶解25-35min，得溶液A；另称取聚乳酸4-7g，与溶液A混合，在不断搅拌下加入二氯甲烷40-60ml溶解，得溶液B。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤b为，制备打印溶液：称取丹参酮IIA原料药500mg，加10mL乙醇，在超声仪中溶解30min，得溶液A；另称取聚乳酸5g，与溶液A混合，在不断搅拌下加入二氯甲烷50ml溶解，得溶液B。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤c中，圆筒的转速为10-40r/min，3D打印针筒的打印针头为23G或者25G，压强是200-300MPa。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤c中，圆筒的转速为20r/min，3D打印针筒的打印针头为25G，打印针头的外径为0.5mm，内径为0.25mm，压强是250MPa。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤d为，将血管支架样品经过烘箱33-45℃干燥、冷却后，得血管支架成品。
前述的基于3D打印的丹参酮ⅡA血管支架的制备方法中，所述步骤d为，将血管支架样品经过烘箱37℃干燥、冷却后，得血管支架成品。
与现有技术相比，本发明在PLA中加入TA，使用3D打印技术成功构建了具有良好力学强度的含药血管支架，TA在PLA支架中有效均匀分布，载药量高达30.43％，792h仅释放了药物的6.44％。该心血管支架在植入生物体初期，有效支撑病变部位血管壁，避免血管急性回弹并维持其通畅之后，随着病变部位狭窄血管的血管功能的逐步重建与自我修复，支架在4-6个月内逐渐被降解吸收，毫无残留；并结合了TA扩张血管、抗凝血、抗血栓、改善微循环障碍、保护引起的血管内皮细胞损伤等作用，使血管的舒缩活动及血管内皮细胞功能恢复到正常的生理状态，减少由于血管内皮损伤所导致的血管再狭窄和血栓形成的发生概率，减少由于支架安装导致的血管内皮二次损伤，及进一步导致的血管再狭窄和血栓再形成，减少患者在接受血管支架治疗后，服用抗凝药物和抗血栓药物带来的经济负担，提高患者的生活质量。
因此，本发明既具有减少血管再狭窄、血栓形成、血管壁损概率的特点，又具有载药量高、药物有效均匀分布、释放时间长的特点。
附图说明
图1是实施例的血管支架成品图；
图2是25G的打印针头分别在10r/min、20r/min、30r/min、40r/min的圆筒转速下打印得到的血管支架样品图。
具体实施方式
下面结合实施例对本发明作进一步的说明，但并不作为对本发明限制的依据。
实施例。
本发明中采用的各个药品为：
丹参酮IIA原料药(西安昊安公司，98％，批号：HXDST2A140110)；
聚乳酸PLA(300KD，东莞市展阳高分子材料有限公司)；
乙醇(分析纯，昆山金城试剂有限公司，批号：20190618)；
二氯甲烷(分析纯，上海试四赫维化工有限公司)；
本发明中采用的各个仪器为:
电子天平(FA2004B，上海佑科仪器仪表有限公司)；
JN-3200D超声波清洗机(宁波江南仪器厂)；
JJ-1精密电动搅拌器(江苏省金坛市鸿科仪器厂)；
现有技术中的3D打印机和3D打印软件；
RC膜透析袋(Mw＝8000-14000，MD34，北京solarbio有限公司)；
UV-5800PC型紫外分光光度计(上海元析仪器有限公司)。
基于3D打印的丹参酮ⅡA血管支架的制备方法，包括以下步骤：
a、建模：用计算机建模软件设计血管支架的3D模型，得建模数据；
b、制备打印溶液：称取丹参酮IIA原料药500mg，加10mL乙醇，在超声仪中溶解30min，得溶液A；另称取聚乳酸5g，与溶液A混合，在不断搅拌下加入二氯甲烷50ml溶解，得溶液B；
c、3D打印血管支架：将建模数据输入3D打印机的程序中，将溶液B装入3D打印针筒，制备与血管内径大小一致的圆筒，转动圆筒，圆筒的转速为10-40r/min，从3D打印针筒内挤出溶液B，3D打印针筒的打印针头为25G，打印针头的外径为0.5mm，内径为0.25mm，压强是250MPa，因二氯甲烷的挥发性极强，打印针头的参数设计和压强设计，保证出料均匀性，打印到圆筒表面，得血管支架样品；
d、将血管支架样品经过烘箱37℃干燥、冷却后，得血管支架成品。血管支架成品如图1所示。制得的血管支架成品，表面光滑，网格状分明，间隙均匀、适度。载药量高达30.43％，载药均匀。
此外，还做了打印针头为25G时，圆筒转速分别为10r/min、20r/min、30r/min、40r/min的情况下打印得到的血管支架样品。如图2所示。图中从左向右依次是10r/min、20r/min、30r/min、40r/min的圆筒转速下打印得到的血管支架样品。
从图2中可以明显看出，25G的针头在20r/min的打印速度下打印得到的血管支架样品最好。

Claims (7)

1.基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：包括以下步骤：
a、建模：用计算机建模软件设计血管支架的3D模型，得建模数据；
b、制备打印溶液：称取丹参酮IIA原料药400-1000mg，加5-20mL乙醇，在超声仪中溶解20-40min，得溶液A；另称取聚乳酸2-10g，与溶液A混合，并加入二氯甲烷30-80ml溶解，得溶液B；
c、3D打印血管支架：将建模数据输入3D打印机的程序中，将溶液B装入3D打印针筒，制备与血管内径大小一致的圆筒，转动圆筒，从3D打印针筒内挤出溶液B，打印到圆筒表面，得血管支架样品；
d、将血管支架样品经过烘干、冷却后，得血管支架成品。
2.根据权利要求1所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤b为，制备打印溶液：称取丹参酮IIA原料药450-550mg，加8-15mL乙醇，在超声仪中溶解25-35min，得溶液A；另称取聚乳酸4-7g，与溶液A混合，在不断搅拌下加入二氯甲烷40-60ml溶解，得溶液B。
3.根据权利要求2所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤b为，制备打印溶液：称取丹参酮IIA原料药500mg，加10mL乙醇，在超声仪中溶解30min，得溶液A；另称取聚乳酸5g，与溶液A混合，在不断搅拌下加入二氯甲烷50ml溶解，得溶液B。
4.根据权利要求1所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤c中，圆筒的转速为10-40r/min，3D打印针筒的打印针头为23G或者25G，压强是200-300MPa。
5.根据权利要求4所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤c中，圆筒的转速为20r/min，3D打印针筒的打印针头为25G，打印针头的外径为0.5mm，内径为0.25mm，压强是250MPa。
6.根据权利要求1所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤d为，将血管支架样品经过烘箱33-45℃干燥、冷却后，得血管支架成品。
7.根据权利要求6所述的基于3D打印的丹参酮ⅡA血管支架的制备方法，其特征在于：所述步骤d为，将血管支架样品经过烘箱37℃干燥、冷却后，得血管支架成品。
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