CN108853563A - 一种可吸收缝合线的制备方法 - Google Patents
一种可吸收缝合线的制备方法 Download PDFInfo
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- CN108853563A CN108853563A CN201810669285.6A CN201810669285A CN108853563A CN 108853563 A CN108853563 A CN 108853563A CN 201810669285 A CN201810669285 A CN 201810669285A CN 108853563 A CN108853563 A CN 108853563A
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Abstract
本发明公开了一种可吸收缝合线的制备方法，属于医药领域。本发明通过加入交联剂，同时引入了胶原和壳聚糖，提高了与细胞组织的黏合，修复，促进组织再生修复，细胞组织的激活有利于缝合部分局部的细胞生物活性提高，促进了可吸收缝合线的吸收降解，从而提高治愈效果。本发明解决了目前化学合成线吸收慢，易对切口新生组织造成勒伤、与机体相容性差的问题。
Description
技术领域
本发明属于医药领域，具体涉及一种可吸收缝合线的制备方法。
背景技术
缝合线是外科手术中最基本、最重要的材料之一，主要用于各种组织缝扎止血、残腔闭锁及组织对合。医用缝合线属于生物降解材料中的一种，用于伤口愈合、组织结扎和组织固定，对伤口的初期愈合有很重要的作用。一般可分为可吸收线和不可吸收线两大类，不可吸收缝合线在体内不降解，如不取出则作为身体异物留在组织中，较容易引起组织感染；可吸收缝合线在身体组织内通过酸、碱或酶作用降解，降解速度取决于组织的温度、PH值及缝合线周围的液态环境，降解后产物转化为人体的代谢产物和***物，无毒无害。与非吸收缝合线相比，可吸收缝合线的主要优点是：无抗原性（只在吸收时产生轻微的组织反应）；无致热性；伤口愈合完整；无须拆线，减轻了病人痛苦，减少了诱发感染的机会。因而，可吸收缝合线是外科缝合线发展的趋势。目前常用的可吸收缝合线多为羊肠线、高分子化学合成线，在实际使用时化学合成线吸收慢，不利于加快伤口恢复速度，易对切口新生组织造成勒伤，形成少量疤痕。因此，生产出一种能解决上述问题的缝合线具有很大的市场前景。
发明内容
本发明所要解决的技术问题：针对目前化学合成线吸收慢，易对切口新生组织造成勒伤、与机体相容性差的问题，提供一种可吸收缝合线的制备方法。
为解决上述技术问题，本发明采用如下所述的技术方案是：
一种可吸收缝合线的制备方法包括如下步骤：
（1）取L-赖氨酸盐酸盐按质量比7~12：2~4加入1,4-丁二醇搅拌混合，再加入樟脑磺酸、甲苯搅拌混合，得搅拌混合物，取搅拌混合物按质量比1~5：3~7加入异丙醇搅拌混合，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比2~5：3~8：10~15加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合30~40min，得搅拌混合物A，取复合抗菌剂按质量比1~3：7~10加入三乙胺，得混合液，取搅拌混合物A按质量比10~20：2~5加入混合液搅拌混合，得混合物；
（3）取混合物按质量比80~90：10~20：1~3加入过硫酸铵、四甲基乙二胺搅拌混合，得基体物，取基体物浸泡至丙酮中2~3h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比2~5：1~3：10~13加入PHBV、1,4-二氧六环，于25~30℃搅拌混合，再加入聚乳酸质量20~30%的聚乙烯吡咯烷酮，熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：3~5浸泡至质量分数为60%的乙醇中，搅拌混合，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比1~3：9~12加入异丙醇搅拌混合，得浸泡液，取浸泡后缝合线基体物按质量比1：5~8加入浸泡液中浸泡，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比2~5：8~15加入质量分数为1%的戊二醛水溶液，于25~35℃静置，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比2~5：10~15加入去离子水混合，得混合液，取胶原、壳聚糖按质量比2~5：1~3：8~12加入乙酸搅拌混合，得混合液a，取洗涤物按质量比10~30：8~13：10~15加入混合液、混合液a，于2~4℃静置，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
所述步骤（1）中樟脑磺酸和甲苯的加入量分别为L-赖氨酸盐酸盐质量的3~6%和10~20%。
所述步骤（1）中搅拌混合物的搅拌条件为：升温至115~125℃搅拌混合1~2h。
所述步骤（1）中减压蒸馏物的生成条件为：于65~70℃搅拌混合40~50min，再于-20~-15℃保温10~15h，减压蒸馏，即得。
所述步骤（2）中复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比3~5：1~3：3~7混合，即得。
所述步骤（3）中基体物的搅拌条件为：于70~80℃搅拌混合30~50min。
所述步骤（5）中熔融纺丝条件为：于熔融纺丝机中，升温至90~110℃熔融纺丝。
本发明与其他方法相比，有益技术效果是：
（1）本发明以L-赖氨酸盐酸与1,4-丁二醇为原料进行聚合反应，形成醇酯型单体，再加入聚乙二醇二丙烯酸酯，并负载苯扎氯铵、红霉素等杀菌消炎药物，整个体系在过硫酸铵和四甲基乙二胺自由基体系的交联作用下，形成水凝胶，将其负载于可缝合线基体表面，缝合时血液中水的作用下溶胀至一个平衡体系，形成三维空间网络结构，可以帮助吸收溢出血液达到止血功效，与细胞膜受体的肽配位体共价结合，从而刺激凝胶基体内细胞的粘附和生长，同时对负载的抗菌性药物进行缓释，在缝合后，对伤口局部的细胞组织进行消炎杀菌，防止感染，形成的水凝胶在人体胰蛋白酶的降解作用下，形成纳米水凝胶，对人体没有伤害；
（2）本发明以聚L-乳酸、PHBV（3-羟基丁酸酯和3-羟基戊酸酯的共聚物）、聚乙烯吡咯烷酮为基料，聚L-乳酸机械强度适宜，纤维柔韧性好，有弹性，对切口新生组织不会造成勒伤，其打结性、持结性符合临床手术要求，同时其在人体内分解的中间产物为L-乳酸是人体的正常代谢产物，属人体内源性活性物质，无毒、无致畸可能性，但其亲水性较弱，不利于细胞进入孔隙、黏附生长，本发明加入聚烯丙基胺，其中的活性胺基与加入的缝合线基体物分子链中的酯基进行胺解反应，胺解过程中引入羟基，提高了亲水性能，同时胺基的碱性能中和酸性中间产物中的羧基从而降低植入材料周围因羧基引起的局部炎症，改善组织相容性，加入PHBV（3-羟基丁酸酯和3-羟基戊酸酯的共聚物）提高了在纺丝过程中热稳定性，形成力学性能较好的可吸收缝合线，同时聚乙烯吡咯烷酮的引入加强了缝合线亲水性、生物相容性，于聚乳酸基体形成优势互补，同时加快了可吸收缝合线的降解速率；
（3）本发明通过加入交联剂，同时引入了胶原和壳聚糖，提高了与细胞组织的黏合，修复，促进组织再生修复，细胞组织的激活有利于缝合部分局部的细胞生物活性提高，促进了可吸收缝合线的吸收降解，从而提高治愈效果。
具体实施方式
一种可吸收缝合线的制备方法，包括如下步骤：
复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比3~5：1~3：3~7混合，即得。
取L-赖氨酸盐酸盐按质量比7~12：2~4加入1,4-丁二醇，搅拌混合20~30min，再加入L-赖氨酸盐酸盐质量3~6%的樟脑磺酸和L-赖氨酸盐酸质量10~20%的甲苯，升温至115~125℃搅拌混合1~2h，得搅拌混合物，取搅拌混合物按质量比1~5：3~7加入异丙醇，于65~70℃搅拌混合40~50min，再于-20~-15℃保温10~15h，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比2~5：3~8：10~15加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合30~40min，得搅拌混合物A，取复合抗菌剂按质量比1~3：7~10加入三乙胺，得混合液，取搅拌混合物A按质量比10~20：2~5加入混合液，搅拌混合40~60min，得混合物；
（3）取混合物按质量比80~90：10~20：1~3加入过硫酸铵、四甲基乙二胺，于70~80℃搅拌混合30~50min，得基体物，取基体物浸泡至丙酮中2~3h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比2~5：1~3：10~13加入PHBV、1,4-二氧六环，于25~30℃搅拌混合20~30min，再加入聚乳酸质量20~30%的聚乙烯吡咯烷酮，于熔融纺丝机中，升温至90~110℃熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：3~5浸泡至质量分数为60%的乙醇中，搅拌混合2~3h，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比1~3：9~12加入异丙醇，搅拌混合30~40min，得浸泡液，取浸泡后缝合线基体物按质量比1：5~8加入浸泡液中，于30~40℃浸泡3~5h，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比2~5：8~15加入质量分数为1%的戊二醛水溶液，于25~35℃静置3~4h，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比2~5：10~15加入去离子水混合，得混合液，取胶原、壳聚糖按质量比2~5：1~3：8~12加入乙酸，搅拌混合30~40min，得混合液a，取洗涤物按质量比10~30：8~13：10~15加入混合液、混合液a，于2~4℃静置18~24h，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
一种可吸收缝合线的制备方法，包括如下步骤：
复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比3：1：3混合，即得。
取L-赖氨酸盐酸盐按质量比7：2加入1,4-丁二醇，搅拌混合20min，再加入L-赖氨酸盐酸盐质量3%的樟脑磺酸和L-赖氨酸盐酸质量10%的甲苯，升温至115℃搅拌混合1h，得搅拌混合物，取搅拌混合物按质量比1：3加入异丙醇，于65℃搅拌混合40min，再于-20℃保温10h，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比2：3：10加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合30min，得搅拌混合物A，取复合抗菌剂按质量比1：7加入三乙胺，得混合液，取搅拌混合物A按质量比10：2加入混合液，搅拌混合40min，得混合物；
（3）取混合物按质量比80：10：1加入过硫酸铵、四甲基乙二胺，于70℃搅拌混合30min，得基体物，取基体物浸泡至丙酮中2h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比2：1：10加入PHBV、1,4-二氧六环，于25℃搅拌混合20min，再加入聚乳酸质量20%的聚乙烯吡咯烷酮，于熔融纺丝机中，升温至90℃熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：3浸泡至质量分数为60%的乙醇中，搅拌混合2h，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比1：9加入异丙醇，搅拌混合30min，得浸泡液，取浸泡后缝合线基体物按质量比1：5加入浸泡液中，于30℃浸泡3h，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比2：8加入质量分数为1%的戊二醛水溶液，于25℃静置3h，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比2：10加入去离子水混合，得混合液，取胶原、壳聚糖按质量比2：1：8加入乙酸，搅拌混合30min，得混合液a，取洗涤物按质量比10：8：10加入混合液、混合液a，于2℃静置18h，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
一种可吸收缝合线的制备方法，包括如下步骤：
复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比5：3：7混合，即得。
取L-赖氨酸盐酸盐按质量比12：4加入1,4-丁二醇，搅拌混合30min，再加入L-赖氨酸盐酸盐质量6%的樟脑磺酸和L-赖氨酸盐酸质量20%的甲苯，升温至125℃搅拌混合2h，得搅拌混合物，取搅拌混合物按质量比5：7加入异丙醇，于70℃搅拌混合50min，再于-15℃保温15h，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比5：8：15加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合40min，得搅拌混合物A，取复合抗菌剂按质量比3：10加入三乙胺，得混合液，取搅拌混合物A按质量比20：5加入混合液，搅拌混合60min，得混合物；
（3）取混合物按质量比90：20：3加入过硫酸铵、四甲基乙二胺，于80℃搅拌混合50min，得基体物，取基体物浸泡至丙酮中3h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比5：3：13加入PHBV、1,4-二氧六环，于30℃搅拌混合30min，再加入聚乳酸质量30%的聚乙烯吡咯烷酮，于熔融纺丝机中，升温至110℃熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：5浸泡至质量分数为60%的乙醇中，搅拌混合3h，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比3：12加入异丙醇，搅拌混合40min，得浸泡液，取浸泡后缝合线基体物按质量比1：8加入浸泡液中，于40℃浸泡5h，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比5：15加入质量分数为1%的戊二醛水溶液，于35℃静置4h，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比5：15加入去离子水混合，得混合液，取胶原、壳聚糖按质量比5：3：12加入乙酸，搅拌混合40min，得混合液a，取洗涤物按质量比30：13：15加入混合液、混合液a，于4℃静置24h，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
一种可吸收缝合线的制备方法，包括如下步骤：
复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比4：2：5混合，即得。
取L-赖氨酸盐酸盐按质量比9：3加入1,4-丁二醇，搅拌混合25min，再加入L-赖氨酸盐酸盐质量4%的樟脑磺酸和L-赖氨酸盐酸质量15%的甲苯，升温至120℃搅拌混合1h，得搅拌混合物，取搅拌混合物按质量比3：5加入异丙醇，于67℃搅拌混合45min，再于-10℃保温13h，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比4：5：13加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合35min，得搅拌混合物A，取复合抗菌剂按质量比2：8加入三乙胺，得混合液，取搅拌混合物A按质量比15：3加入混合液，搅拌混合50min，得混合物；
（3）取混合物按质量比85：15：2加入过硫酸铵、四甲基乙二胺，于75℃搅拌混合40min，得基体物，取基体物浸泡至丙酮中2h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比3：2：12加入PHBV、1,4-二氧六环，于27℃搅拌混合25min，再加入聚乳酸质量25%的聚乙烯吡咯烷酮，于熔融纺丝机中，升温至100℃熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：4浸泡至质量分数为60%的乙醇中，搅拌混合2h，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比2：10加入异丙醇，搅拌混合35min，得浸泡液，取浸泡后缝合线基体物按质量比1：6加入浸泡液中，于35℃浸泡4h，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比3：12加入质量分数为1%的戊二醛水溶液，于30℃静置3h，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比3：13加入去离子水混合，得混合液，取胶原、壳聚糖按质量比3：2：10加入乙酸，搅拌混合35min，得混合液a，取洗涤物按质量比20：11：13加入混合液、混合液a，于3℃静置21h，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
对比例：广州市某公司生产的可吸收缝合线。
选取人群：在三所医院筛选需进行手术的患者200例，年龄15~65岁，男性患者100例，女性患者100例，所有患者均自愿进行试验，并遵从试验安排进行随访。
实验组使用本发明所得一种可吸收缝合线；对照组使用对比例缝合线，观察并记录患者的手术缝合线使用效果。测试结果见表1。
表1：
| 测试项目 | 实施例1 | 实施例2 | 实施例3 | 对比例 |
| 伤口愈合时间（天） | 13 | 12 | 13 | 15~17 |
| 过敏反应例数 | 0 | 0 | 0 | 1~3 |
| 30天后缝合线吸收情况 | 完全吸收 | 完全吸收 | 完全吸收 | 部分吸收 |
| 疤痕情况 | 基本无 | 基本无 | 基本无 | 有明显疤痕 |
综合上述，本发明的可吸收缝合线伤口愈合时间短，30天内可完全吸收，避免二次拆线，使用效果明显优于对比例，因此可广泛使用。
Claims (7)
1.一种可吸收缝合线的制备方法，其特征在于，该制备方法包括如下步骤：
（1）取L-赖氨酸盐酸盐按质量比7~12：2~4加入1,4-丁二醇搅拌混合，再加入樟脑磺酸、甲苯搅拌混合，得搅拌混合物，取搅拌混合物按质量比1~5：3~7加入异丙醇搅拌混合，减压蒸馏，得减压蒸馏物；
（2）取减压蒸馏物按质量比2~5：3~8：10~15加入聚乙二醇二丙烯酸酯、N,N-二甲基乙酰胺搅拌混合30~40min，得搅拌混合物A，取复合抗菌剂按质量比1~3：7~10加入三乙胺，得混合液，取搅拌混合物A按质量比10~20：2~5加入混合液搅拌混合，得混合物；
（3）取混合物按质量比80~90：10~20：1~3加入过硫酸铵、四甲基乙二胺搅拌混合，得基体物，取基体物浸泡至丙酮中2~3h，取出基体物经无菌水洗涤，冷冻干燥，得冷冻干燥物，备用；
（4）取聚L-乳酸按质量比2~5：1~3：10~13加入PHBV、1,4-二氧六环，于25~30℃搅拌混合，再加入聚乳酸质量20~30%的聚乙烯吡咯烷酮，熔融纺丝，得缝合线基体物，取缝合线基体物按质量比1：3~5浸泡至质量分数为60%的乙醇中，搅拌混合，取出浸泡后缝合线基体物，取聚烯丙基胺按质量比1~3：9~12加入异丙醇搅拌混合，得浸泡液，取浸泡后缝合线基体物按质量比1：5~8加入浸泡液中浸泡，取出浸泡物经无菌水洗涤，干燥，得干燥缝合线基料；
（5）取干燥缝合线基料按质量比2~5：8~15加入质量分数为1%的戊二醛水溶液，于25~35℃静置，取出浸泡后干燥缝合线基料，经去离子水洗涤，得洗涤物，取步骤（3）备用的冷冻干燥物按质量比2~5：10~15加入去离子水混合，得混合液，取胶原、壳聚糖按质量比2~5：1~3：8~12加入乙酸搅拌混合，得混合液a，取洗涤物按质量比10~30：8~13：10~15加入混合液、混合液a，于2~4℃静置，过滤，取出纺丝经水漂洗，干燥，即得可吸收缝合线。
2.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（1）中樟脑磺酸和甲苯的加入量分别为L-赖氨酸盐酸盐质量的3~6%和10~20%。
3.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（1）中搅拌混合物的搅拌条件为：升温至115~125℃搅拌混合1~2h。
4.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（1）中减压蒸馏物的生成条件为：于65~70℃搅拌混合40~50min，再于-20~-15℃保温10~15h，减压蒸馏，即得。
5.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（2）中复合抗菌剂：苯扎氯铵、红霉素、洗必泰按质量比3~5：1~3：3~7混合，即得。
6.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（3）中基体物的搅拌条件为：于70~80℃搅拌混合30~50min。
7.根据权利要求1所述的可吸收缝合线的制备方法，其特征在于，所述步骤（5）中熔融纺丝条件为：于熔融纺丝机中，升温至90~110℃熔融纺丝。
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