Determination of the in Vitro Degradation Products of Poly(Lactide-Co-Glycolide) Stent Coating by High Performance Liquid Chromatography
摘 要
为了考察新型可吸收锌合金药物洗脱冠脉支架系统(简称支架)中聚合物涂层的体外降解性能,进行了题示项目的研究。将支架悬吊于50 mL离心管中,用已预热至37℃的10 mL磷酸盐缓冲液浸没,并于37℃振荡。分别在0,7,14,21,28 d时取降解液,用磷酸调节pH至2.8±0.2,经0.20 μm滤膜过滤后采用高效液相色谱法测定,并对降解过程中支架的表观形貌进行观察,进而评估药物涂层的降解情况。结果表明,降解产物乙醇酸和L-乳酸的质量浓度在一定范围内与其峰面积呈线性关系,检出限(3S/N)分别为0.50,0.70 mg·L-1。对空白加标水样进行精密度试验,相对标准偏差(n=6)为0.12%~2.7%。对空白样品进行加标回收试验,回收率为91.6%~118%。由降解产物的累积量可知,28 d支架中的聚合物涂层基本完全降解。
Abstract
In order to investigate the in vitro degradation of polymer coating in a new absorbable zinc alloy drug-eluting coronary stent system (stent), the work as mentioned by the title was done. The stent was suspended in a 50 mL centrifuge tube, and 10 mL of phosphate buffer solution preheated to 37℃ was added to immerse the stent, which was shaking at 37℃. On 0, 7, 14, 21, 28 d, the degradation solution was collected, adjusted to pH 2.8±0.2 with phosphoric acid, filtered through 0.20 μm membrane, and determined by high performance liquid chromatography. The morphology was observed to evaluate the degradation of the drug coating. As shown by the results, linear relationships between values of peak area and mass concentration of glycolic acid and L-lacticacid were found in definite ranges, with detection limits (3S/N) of 0.50 mg·L-1 and 0.70 mg·L-1, respectively. Test for precision was carried out on blank spiked water samples, with RSDs (n=6) in the range of 0.12%-2.7%. Test for recovery was made on the blank samples by standard addition method, giving results in the range of 91.6%-118%. According to the cumulative amounts of degradation products, the polymer coating in the stent was basically completely degraded in 28 d.
中图分类号 O652.63 DOI 10.11973/lhjy-hx202209003
所属栏目 工作简报
基金项目 国家重点研发计划项目(2016YFC1102500)
收稿日期 2021/2/22
修改稿日期
网络出版日期
作者单位点击查看
联系人作者施燕平(sdzxsyp@163.com)
备注杜福映,工程师,主要从事医疗器械检测与评价
引用该论文: DU Fuying,ZHANG Huamei,WU Changyan,CHEN Fang,LIU Lili,ZHAO Changshuai,PENG Jian,SHEN Yong,SHI Yanping. Determination of the in Vitro Degradation Products of Poly(Lactide-Co-Glycolide) Stent Coating by High Performance Liquid Chromatography[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2022, 58(9): 1005~1009
杜福映,张花美,吴长岩,陈方,刘莉莉,赵长帅,彭健,沈永,施燕平. 高效液相色谱法测定聚丙交酯乙交酯支架涂层的体外降解产物的含量[J]. 理化检验-化学分册, 2022, 58(9): 1005~1009
共有人对该论文发表了看法,其中:
人认为该论文很差
人认为该论文较差
人认为该论文一般
人认为该论文较好
人认为该论文很好
参考文献
【1】MATSUI S, IKEDA S, AONO J, et al. A case of coronary artery aneurysm after sirolimus-eluting stent implantation presenting with unstable angina due to progression of stent thrombosis:Concerns over sirolimus-eluting stents remain[J]. Journal of Cardiology Cases, 2016,14(6):168-170.
【2】CAMENZIND E, STEG P G, WIJNS W. Stent thrombosis late after implantation of first-generation drug-eluting stents:Acause for concern[J]. Circulation, 2007,115(11):1440-1455.
【3】FINN A V, GAKU N, MICHAEL J, et al. Vascular responses to drug eluting stents:Importance of delayed healing[J]. Arteriosclerosis,Thrombosis,and Vascular Biology, 2007,27(7):1500-1510.
【4】JELONEK K, JAWORSKA J, PASTUSIAK M, et al. Effect of vascular scaffold composition on release of sirolimus[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2018,132:41-49.
【5】LI F Q, GU Y Q, HUA R X, et al. In vitro release study of sirolimus from a PDLLA matrix on a bioresorbable drug-eluting stent[J]. Journal of Drug Delivery Science and Technology, 2018,48:88-95.
【6】RAVAL A, BAHADUR P, RAVAL A. Effect of nonionic surfactants in release media on accelerated in-vitro release profile of sirolimus eluting stents with biodegradable polymeric coating[J]. Journal of Pharmaceutical Analysis, 2018,8(1):45-54.
【7】徐克,夏永辉,冯博,等.雷帕霉素-多聚丙交酯乙交酯药膜洗脱支架结构设计和体外药代动力学研究[J].中国介入影像与治疗学, 2007,4(6):473-477.
【8】邹凤平,姚天平,颜文涛,等.雷帕霉素药物洗脱支架的体外释放性能研究[J].药物分析杂志, 2017,37(11):2048-2052.
【9】RAVAL A, PARIKH J, ENGINEER C. Mechanism and in vitro release kinetic study of sirolimus from a biodegradable polymeric matrix coated cardiovascular stent[J]. Industrial & Engineering Chemistry Research, 2011,50:9539-9549.
【10】ZHANG H J, LI X D, DENG W, et al. Drug release kinetics from a drug-eluting stent with asymmetrical coat[J]. Frontiers in Bioscience, 2017,22:407-415.
【11】王忠新,谭海颂,曹磊,等.新型生物可降解雷帕霉素药物洗脱输尿管支架的构建及性能评估[J].海南医学, 2014,25(18):2663-2666.
【12】李霞.医用镁合金植入体表面杂化涂层的制备及其性能研究[D].武汉:湖北大学, 2016.
【13】王槐豪.镁表面阳极氧化-PLGA生物涂层的腐蚀降解行为研究[D].哈尔滨:哈尔滨工业大学, 2013.
【14】MODI N R, PATEL C K, MEWADA P S, et al. Stent coating:Recent advances in pharmaceutical coating[J]. Research Journal of Pharmacy and Technology, 2013,3(3):712-720.
【15】魏志勇,刘炼,张萌,等.聚乳酸、乳酸乙醇酸共聚物的制备及其体外降解[J].生物医学工程学杂志, 2008,25(1):122-126.
【16】周超,闫玉华.聚乳酸-乙醇酸共聚物合成与降解[J].生物骨科材料与临床研究, 2006,3(5):50-53.
【2】CAMENZIND E, STEG P G, WIJNS W. Stent thrombosis late after implantation of first-generation drug-eluting stents:Acause for concern[J]. Circulation, 2007,115(11):1440-1455.
【3】FINN A V, GAKU N, MICHAEL J, et al. Vascular responses to drug eluting stents:Importance of delayed healing[J]. Arteriosclerosis,Thrombosis,and Vascular Biology, 2007,27(7):1500-1510.
【4】JELONEK K, JAWORSKA J, PASTUSIAK M, et al. Effect of vascular scaffold composition on release of sirolimus[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2018,132:41-49.
【5】LI F Q, GU Y Q, HUA R X, et al. In vitro release study of sirolimus from a PDLLA matrix on a bioresorbable drug-eluting stent[J]. Journal of Drug Delivery Science and Technology, 2018,48:88-95.
【6】RAVAL A, BAHADUR P, RAVAL A. Effect of nonionic surfactants in release media on accelerated in-vitro release profile of sirolimus eluting stents with biodegradable polymeric coating[J]. Journal of Pharmaceutical Analysis, 2018,8(1):45-54.
【7】徐克,夏永辉,冯博,等.雷帕霉素-多聚丙交酯乙交酯药膜洗脱支架结构设计和体外药代动力学研究[J].中国介入影像与治疗学, 2007,4(6):473-477.
【8】邹凤平,姚天平,颜文涛,等.雷帕霉素药物洗脱支架的体外释放性能研究[J].药物分析杂志, 2017,37(11):2048-2052.
【9】RAVAL A, PARIKH J, ENGINEER C. Mechanism and in vitro release kinetic study of sirolimus from a biodegradable polymeric matrix coated cardiovascular stent[J]. Industrial & Engineering Chemistry Research, 2011,50:9539-9549.
【10】ZHANG H J, LI X D, DENG W, et al. Drug release kinetics from a drug-eluting stent with asymmetrical coat[J]. Frontiers in Bioscience, 2017,22:407-415.
【11】王忠新,谭海颂,曹磊,等.新型生物可降解雷帕霉素药物洗脱输尿管支架的构建及性能评估[J].海南医学, 2014,25(18):2663-2666.
【12】李霞.医用镁合金植入体表面杂化涂层的制备及其性能研究[D].武汉:湖北大学, 2016.
【13】王槐豪.镁表面阳极氧化-PLGA生物涂层的腐蚀降解行为研究[D].哈尔滨:哈尔滨工业大学, 2013.
【14】MODI N R, PATEL C K, MEWADA P S, et al. Stent coating:Recent advances in pharmaceutical coating[J]. Research Journal of Pharmacy and Technology, 2013,3(3):712-720.
【15】魏志勇,刘炼,张萌,等.聚乳酸、乳酸乙醇酸共聚物的制备及其体外降解[J].生物医学工程学杂志, 2008,25(1):122-126.
【16】周超,闫玉华.聚乳酸-乙醇酸共聚物合成与降解[J].生物骨科材料与临床研究, 2006,3(5):50-53.
相关信息