呋喃西林涂层尿管的制作方法及药物缓释效果研究

目的 研制可预防尿路感染的呋喃西林洗脱可降解涂层硅橡胶导尿管(新型尿管).方法 以聚乳酸-羟基乙酸共聚物为载体,呋喃西林为抗菌物质,使用浸涂提拉法制造尿管涂层；采用改良高效液相色谱法(RP-HPLC)测定呋喃西林浓度,评估新型尿管的药物缓释效果.结果 以374 nm为紫外检测波长,测得浓度为8.00、24.00、40.00、56.00、80.00 μg/ml呋喃西林溶液的色谱峰面积分别为3.6621×106、10.8524×106、18.3275×106、26.9443×106和36.6285×106,回归方程为:A=4.6464×105C-4.5961×104,r=0.9990,线性关系良好；以该法测得新型尿管涂层连续释放7d的色谱峰面积分别为29.673×105、23.562×105、16.851×10 5、14.524×105、9.562×105、7.395×105和4.231×105,药物释放曲线符合2阶多项式:y=38320×X2-720661×X+4×106,r=0.9969,药物释放的色谱峰面积及相对药物保留浓度都随时间的延长而减少.结论 以14d为界设计的尿管药物涂层缓释效果理想,有望用于预防短期留置尿管感染.

Method of making furacilinum-coated urinary catheter and effect of drug delivery

OBJECTIVE To evaluate the elution profile of furacilinum from the urinary catheter coating(new type catheter).METHODS PLGA polymer was used as a carrier to form a coating with furacilinum on the urinary catheter.The release of furacilinum from the urinary catheter coating was evaluated by high-performance liquid chromatographic method(RP-HPLC)with ultraviolet absorbance detection.RESULTS By using the UV detection wavelength of 374 nm,the measured concentration of 8.00,24.00,40.00,56.00 and 80.00 μg/ml solution of the chromatographic peak area of furacilinum were 3.6621×106,10.8524×106,18.3275×106,26.9443×106 and 36.6285×106 the regression equation:A=4.6464×105C-4.5961×104,r=0.9990,a good linear relationship.The new catheter coating measured by the release of 7-day continuous chromatographic peak area was 29.673×105,23.562×105,16.851×105,14.524×105,9.562×105,7.395×105 and 4.231×105,the drug release curve with 2-order polynomial: y=38320×X2-720661×X+4×106,r=0.9969,the chromatographic peak area of drug release and the relative concentrations of drug retention decreased with time.CONCLUSION Day 14 as the boundary drug-eluting of furacilinum designed to release is expected to the prevention of the infections due to short-term indwelling catheter.