CN105944152A - 可吸收防粘医用膜的制备方法 - Google Patents

可吸收防粘医用膜的制备方法 Download PDF

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CN105944152A
CN105944152A CN201610410049.3A CN201610410049A CN105944152A CN 105944152 A CN105944152 A CN 105944152A CN 201610410049 A CN201610410049 A CN 201610410049A CN 105944152 A CN105944152 A CN 105944152A
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CN105944152B (zh
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吴新谦
张均明
林水东
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Longyan Cercis Innovation Research Institute
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Abstract

本发明公开了可吸收防粘医用膜的制备方法，采用二氯甲烷和乙酸乙酯溶解相对分子质量为120000‑200000的聚乳酸，配制得到聚乳酸浓度为5‑8%的静电纺丝液，再通过静电纺丝工艺形成聚乳酸纳米纤维无纺毡，最后将聚乳酸纳米纤维无纺毡干燥后得到防粘连的可吸收医用膜。本发明工艺简单，制备得到的防粘连医用膜降解时间可控，且质量稳定、柔韧性和拉伸性好。

Description

可吸收防粘医用膜的制备方法
技术领域
本发明涉及医疗用品领域，特别设计一种可吸收防粘医用膜的制备方法。
背景技术
现有外科手术中，常采用防粘连医用膜作为物理屏障来防止术后粘连，避免周围疤痕组织长入与肌腱形成粘连，有效的预防肌腱粘连，能有效遮盖手术部位，可避免血肿的压迫。防粘连膜的选择性通透功能，既可以使滑液等营养物质进入，促进肌腱内源性愈合，又具有一定的透气性，有利于伤口愈合。
一般的防粘连膜均采用生物可吸收医用膜，如聚乳酸膜、透明质酸膜、壳聚糖膜等等。
市售的聚乳酸膜为聚乳酸与乙醇酸共聚物或聚乳酸均聚物的膜，质脆，柔韧性、拉伸性差，降解时间过长，在使用及安全性上都有一定的弊端。而透明质酸膜、壳聚糖膜和氧化纤维素膜，降解时间太短，不能在要求的时间内保持物理屏障的作用，而不能较好地完成防粘连的功能，另外壳聚糖膜柔韧性较差，给临床使用带来许多不便。
近年来也有有关将乳酸、聚乙二醇通过本体聚合的方法共聚，从而制得乳酸/聚乙二醇共聚物生物可降解材料的报道，其制成医用膜的方法主要有压延法、流延法、溶剂蒸发法，上述制备方法的成膜过程长，制备得到的乳酸/聚乙二醇共聚物生物可降解材料的柔韧性不够理想，且降解时间无法控制。
静电纺丝工艺由于其可控性强，应用于生产细胞支架时取得良好的效果。为此本发明人将静电纺丝工艺应用于可吸收防粘医用膜的制备中，然由于可吸收防粘医用膜要求降解时间可控，需要更强的膜强度，为此本发明人通过不断改进，研制出适于静电纺丝制备可吸收防粘医用膜的方法，本案由此产生。
发明内容
本发明提供的可吸收防粘医用膜的制备方法，工艺简单，制备得到的医用膜质量稳定、柔韧性和拉伸性好，且降解时间可调。
为了实现上述目的，本发明的技术方案如下：
可吸收防粘医用膜的制备方法，采用二氯甲烷和乙酸乙酯溶解相对分子质量为120000-200000的聚乳酸，配制得到聚乳酸浓度为5-8%的静电纺丝液，再通过静电纺丝工艺形成聚乳酸纳米纤维无纺毡，最后将聚乳酸纳米纤维无纺毡干燥后得到防粘连的可吸收医用膜。
所述聚乳酸为聚L-乳酸（PLLA）。
所述静电纺丝的条件为，电压12-23kV，喷丝头挤出速度0.02-0.15ml/min，接收距离15-25cm。
所述干燥条件为，将聚乳酸纳米纤维无纺毡放置在15-50℃的干燥箱内干燥3-30小时。
采用上述方案后，本发明通过采用二氯甲烷和乙酸乙酯共同作为溶剂，改善了纺丝过程的稳定性，从而利于提高纺丝后纤维的强度，通过选择不同相对分子质量的聚乳酸，通过改变静电纺丝的工艺条件，即可制备得到体内降解可靠，且具备不同降解时间的可吸收防粘医用膜，并且得到的医用膜厚度均匀，质量稳定，柔韧性和拉伸性好。
具体实施方式
为了进一步解释本发明的技术方案，下面通过具体实施例来对本发明进行详细阐述。
实施例一
将分子量160000的聚L-乳酸(PLLA)5克，加入一定量的二氯甲烷和乙酸乙酯，配制成5%PLLA纺丝液。
将该纺丝液注入注射器中并固定在注射泵上。将喷丝口(针头) 与高压电源阳极输出端相连, 阴极输出端与金属接收屏相接, 这样就在高分子溶液上施加了一个高压静电场。量出两电极间的距离，即喷丝口到阴极接收金属片之间的距离。
静电纺丝条件为，调节电压到15kV及喷丝头挤出速度0.02ml/min, 接收距离15厘米。约4小时后，制得PLLA纳米纤维无纺毡。
然后将纳米纤维无纺毡在50℃的干燥箱内干燥6小时，制备得到可吸收防粘医用膜。制备得到的可吸收防粘医用膜降解时间为14周，其断裂伸长率为96%，拉伸模量为1.05Mpa。
实施例二
将分子量120000的聚L-乳酸(PLLA)5克，加入一定量的二氯甲烷和乙酸乙酯，配制成8%PLLA纺丝液。
将该纺丝液注入注射器中并固定在注射泵上。将喷丝口(针头) 与高压电源阳极输出端相连, 阴极输出端与金属接收屏相接, 这样就在高分子溶液上施加了一个高压静电场。量出两电极间的距离，即喷丝口到阴极接收金属片之间的距离。
静电纺丝条件为，调节电压到20kV及喷丝头挤出速度0.03ml/min, 接收距离18厘米。约4小时后，制得PLLA纳米纤维无纺毡。
然后将PLLA纳米纤维无纺毡在15℃的干燥箱内干燥30小时，制备得到可吸收防粘医用膜。制备得到的可吸收防粘医用膜降解时间为8周，其断裂伸长率为86%，拉伸模量为0.95Mpa。
实施例三
将分子量200000的聚L-乳酸(PLLA)5克，加入一定量的二氯甲烷和乙酸乙酯，配制成6%PLLA纺丝液。
将该纺丝液注入注射器中并固定在注射泵上。将喷丝口(针头) 与高压电源阳极输出端相连, 阴极输出端与金属接收屏相接, 这样就在高分子溶液上施加了一个高压静电场。量出两电极间的距离，即喷丝口到阴极接收金属片之间的距离。
静电纺丝条件为，调节电压到20kV及喷丝头挤出速度0.15ml/min, 接收距离23厘米。约8小时后，制得PLLA纳米纤维无纺毡。
然后将纳米纤维无纺毡在25℃的干燥箱内干燥20小时，制备得到可吸收防粘医用膜。制备得到的可吸收防粘医用膜降解时间为24周，其断裂伸长率为110%，拉伸模量为1.15Mpa。
由本发明方法制备得到的可吸收防粘医用膜的其它性能如下：
医用膜孔径为3-20μm，厚度为15-80μm，纤维直径200-1000nm；
特性粘数：0.4～1.4；
重金属含量：小于10μg/g；
溶血率小于5％；
烧灼残渣：小于0.2％；
无致敏反应；
皮肤刺激试验：无刺激反应；
细胞毒性：小于I级。
以上仅为本发明的较佳实施例，并非对本发明的保护范围的限定。凡依本案的设计思路所做的等同变化，均落入本案的保护范围。

Claims (4)

1.可吸收防粘医用膜的制备方法，其特征在于：采用二氯甲烷和乙酸乙酯溶解相对分子质量为120000-200000的聚乳酸，配制得到聚乳酸浓度为5-8%的静电纺丝液，再通过静电纺丝工艺形成聚乳酸纳米纤维无纺毡，最后将聚乳酸纳米纤维无纺毡干燥后得到防粘连的可吸收医用膜。
2.如权利要求1所述的可吸收防粘医用膜的制备方法，其特征在于：所述聚乳酸为聚L-乳酸（PLLA）。
3.如权利要求1所述的可吸收防粘医用膜的制备方法，其特征在于：所述静电纺丝的条件为，电压12-23kV，喷丝头挤出速度0.02-0.15ml/min，接收距离15-25cm。
4.如权利要求1所述的可吸收防粘医用膜的制备方法，其特征在于：所述干燥条件为，将聚乳酸纳米纤维无纺毡放置在15-50℃的干燥箱内干燥3-30小时。
CN201610410049.3A 2016-06-13 2016-06-13 可吸收防粘医用膜的制备方法 Expired - Fee Related CN105944152B (zh)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104056297A (zh) * 2014-06-18 2014-09-24 四川大学 一种聚乳酸基复合材料手术医用膜及其制备方法
CN104955445A (zh) * 2012-05-09 2015-09-30 优势医疗公司 多晶型物组合物及其制造方法和用途
CN105396181A (zh) * 2015-08-24 2016-03-16 武汉医佳宝生物材料有限公司 一种可降解支架医用膜的制备方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104955445A (zh) * 2012-05-09 2015-09-30 优势医疗公司 多晶型物组合物及其制造方法和用途
CN104056297A (zh) * 2014-06-18 2014-09-24 四川大学 一种聚乳酸基复合材料手术医用膜及其制备方法
CN105396181A (zh) * 2015-08-24 2016-03-16 武汉医佳宝生物材料有限公司 一种可降解支架医用膜的制备方法

Non-Patent Citations (1)

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HAZIM J. HAROOSH等: ""Electrospun PLA/PCL Fibers with Tubular Nanoclay:Morphological and Structural Analysis"", 《JOURNAL OF APPLIED POLYMER SCIENCE》 *

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