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目的制作一种新型可以缓释曲安奈德的胆道支架,观察带药支架药物释放的规律。方法将曲安奈德和聚(DL-乳酸-羟基乙酸)共聚物(PLGA)粉末以20%的带药浓度溶于两者的共同溶剂四氢呋喃(THF)中,并将6Fr胆道引流管浸剪成数个50mm段泡于上述溶剂中,10min后取出真空烘干,常温避光保存。通过测重计算支架所载曲安奈德的质量;采用磷酸盐缓冲液(PBS,pH7.4)将曲安奈德稀释为系列标准液,对240nm紫外分光峰面积进行相关分析。将曲安奈德支架放入8mlPBS中,置于37℃的恒温摇床中持续浸泡48h,然后换新鲜的PBS重复浸泡,直至第40天。以标准PBS液为对照组,对第1～40天留取的浸出液进行色谱分析,计算曲安奈德在浸出液中的浓度。结果称量测得平均每根支架上曲安奈德的负载量为510μg,单位面积的载药量为1.63μg/mm2。曲安奈德均能从支架表面持续释放,前5d浓度波动在6.32～8.78μg/ml,前5d共释放曲安奈德180.61μg,占总释放量的47.23%,之后浓度平稳波动在1.85～3.51μg/ml,第23天后开始降低,第33天的洗脱浓度为0.53μg/ml,随后即不可测得。结论用PLGA作为药物载体能成功制备曲安奈德药物胆道洗脱支架;体外研究表明该药物洗脱支架可持续稳定释放曲安奈德超过30d。
Objective To make a new type of biliary stent that can release triamcinolone acetonide and observe the regularity of drug release with drug-eluting stent. Methods Triamcinolone acetonide and poly (DL-lactide-co-glycolic acid) (PLGA) powder were dissolved in a THF solvent at a concentration of 20%, and the 6Fr biliary drainage tube was dipped into A number of 50mm bubble in the above-mentioned solvent, remove the vacuum drying after 10min, dark at room temperature preservation. The weight of triamcinolone acetonide in scaffolds was calculated by weight measurement. Triamcinolone acetonide was diluted into series standard solution by phosphate buffer (PBS, pH7.4), and correlation analysis was performed on the peak area of 240nm UV spectrophotometer. The triamcinolone acetonide stent into 8mlPBS, placed in a constant temperature shaker at 37 ℃ continued to soak 48h, and then replaced with fresh PBS repeatedly soaked until the 40th day. The standard PBS solution was used as the control group. The leachate collected from day 1 to 40 was analyzed by chromatography, and the concentration of triamcinolone acetonide in the leachate was calculated. RESULTS Weighted mean triamcinolone acetonide loading per stent was 510 μg and drug loading per unit area was 1.63 μg / mm 2. Triamcinolone acetonide sustained release from the stent surface, the concentration fluctuations in the first 5d 6.32 ~ 8.78μg / ml, the first 5d release of triamcinolone acetonide 180.61μg, accounting for 47.23% of the total release, after the steady fluctuations in the concentration of 1.85 ~ 3.51μg / ml, began to decrease after the 23rd day, the elution concentration on the 33rd day was 0.53μg / ml, then it was not measurable. Conclusions Triamcinolone acetonide biliary eluting stent can be successfully prepared using PLGA as drug carrier. In vitro studies show that triamcinolone acetonide can sustainably release triamcinolone acetonide over 30 days.