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丝裂霉素C涂层胆道支架的制作
肖宏生1,12,张明明1,胡冰1*
0
(1.第二军医大学东方肝胆外科医院,上海 200438;
2.南阳医学高等专科学校第一附属医院消化内科,南阳 473058
*通信作者)
摘要:
目的制作一种带有丝裂霉素C(MMC)涂层的胆道支架,观察带药支架药物释放的规律。方法将MMC和聚乳酸-羟基乙酸(PLGA)粉末以1%的带药浓度溶于两者的共同溶剂四氢呋喃中,并将6Fr胆道引流管浸泡于上述溶剂中,10 min后取出,真空烘干,常温避光保存。称量并计算支架MMC载药量。将MMC涂层支架放入8 ml磷酸盐缓冲溶液(PBS, pH 7.4)中,置于37℃的恒温摇床中持续浸泡24 h,然后换新鲜的PBS继续浸泡,重复浸泡30 d。对第1~30天留取的浸出液进行色谱分析,计算MMC在浸出液中的质量浓度。 结果称量测得每根支架上MMC的载药量为(216.20±2.04) μg,单位面积的载药量为(0.732±0.007) μg/mm2。MMC均能从支架表面持续释放,第1天的洗脱浓度为(1.81±0.06) μg/ml,第2天为(1.24±0.04) μg/ml,之后波动在0.61~0.84 μg/ml范围内,第21天后开始略降低,第30天为(0.51±0.01) μg/ml。结论用PLGA作为药物载体能成功制备MMC涂层胆道支架,体外研究表明该药物涂层支架可持续稳定释放MMC超过30 d。
关键词:  药物洗脱支架  丝裂霉素C  聚乳酸  药物缓释
DOI:10.3724/SP.J.1008.2012.001245
投稿时间:2012-05-17修订日期:2012-09-06
基金项目:上海市科委课题(114119a6600).
Preparation of mitomycin C-eluting stent for biliary tract
XIAO Hong-sheng1,12,ZHANG Ming-ming1,HU Bing1*
(1. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China;
2. Department of Gastroenterology, The First Affiliated Hospital of Nanyang Medical College, Nanyang 473058, Henan, China
*Corresponding author.)
Abstract:
Objective To prepare a mitomycin C (MMC)-eluting stent for biliary tract, and to observe the drug delivery from the stent. MethodsThe mixed powder of MMC and polylactic glycolic acid (PLGA) was dissolved with their common solvent tetrahydrofuran (THF), with a drug concentration of 1%. The 6Fr biliary stent was soaked in the above solution for 10 min, and then was subjected to vacuum drying and was stored at room temperature. Then MMC-eluting stent was weighed and the MMC load was calculated. The MMC-eluting stents were soaked in 8 ml phosphate buffered saline (PBS, pH 7.4)and placed in a shaker at a constant temperature of 37℃ for 24 h soaking; then fresh PBS was changed every day for 30 days. The leaching solutions of the 1-30 days were subjected to chromatographic analysis to determine the concentrations of MMC. Results MMC load on each stent was (216.20±2.04) μg, with the load per unit area being (0.732±0.007) μg/mm2. MMC could be released from the stent surface in a sustainable manner. The elution concentration of MMC was (1.81±0.06) μg/ml on first day and (1.24±0.04) μg/ml on the second day; then it fluctuated within 0.61-0.84 μg/ml. The concentration of MMC began to decrease from the 21st day, and it was (0.51±0.01) μg/ml on the 30th day. Conclusion MMC-eluting biliary stents can be successfully prepared using polylactic acid as a drug carrier. In vitro study shows that the drug-eluting stents can sustainably and stably release MMC for over 30 days.
Key words:  drug-eluting stents  mitomycin C  polylactic glycolic acid  drug sustained-release