可吸收聚乳酸-替硝唑抗菌缓释剂体外药物释放效果的测定
Dynamic Release of Tinidazole from the Degradable PLLA-tinidazole Blend Gel
作者：刘娟,肖丽英,李伟,丁一,张萍,袁明龙
Author：LIUJuan1,XIAO Li-ying1,LI Wei1, DING Yi1,ZHANG Ping1,YUANMing-long2
收稿日期：2005-06-25 年卷（期）页码：2005,23(03):237-
期刊名称：华西口腔医学杂志
Journal Name：West China Journal of Stomatology
关键字：高效液相色谱法,聚乳酸,替硝唑,
Key words：high-performance liquid chromatography,poly-lactic acid,tinidazole,
基金项目：
教育部留学回国人员科研启动基金资助项目 (0040305402005)
中文摘要
目的 用高效液相色谱法(HPLC)测定可吸收聚乳酸-替硝唑抗菌缓释剂中替硝唑的体外释放动力学,以
观察聚乳酸-替硝唑共混缓释剂在作为抗牙周炎治疗剂时的药物持续释放时间和有效释放浓度。方法 采用C18
色谱柱分离,以水-甲醇-冰醋酸为流动相,流速为1·5 ml/min,测试波长为310 nm,柱温为30℃,测定可吸收聚乳
酸-替硝唑抗菌缓释剂中替硝唑的持续释放时间和有效释放浓度。结果 ①替硝唑的保留时间约为12 min。②混
合凝胶中替硝唑的浓度与峰面积呈良好的线性关系,方程:y=0·836+8·452 2×10-5x(r=0·998 6),线性范围为
5~500 mg/L,相对标准差为0·2%。③聚乳酸对替硝唑的测定无干扰。替硝唑平均每日释放度为5·60%,14 d累计
释放度约为78·40%。结论 聚乳酸-替硝唑共混缓释剂具有较长时间保持有效抑菌浓度的药物释放能力;HPLC
是评价局部药物释放剂简便、准确和具有良好重复性的有效方法。
英文摘要
Objective To determine the dynamic release of tinidazole from the degradable poly-lactic acid (PLLA)-tinidazole blend gel (a periodontal local drug delivery) by high-performance liquid chromatography (HPLC)in vitroand to observe the poly- lactic acid (as a vector of tinidazole) howto affect the release of tinidazole.Methods HPLC analysiswas conducted. The oper- ating conditions were C18-ODS-A column, water-methanol-acetic acid as mobile phase at a flowrate of 1·5 ml/min and a detection wavelength at 310 nm and a column temperature at 30℃.Results ①The retention time of tinidazole was about 12 min. ②There was good linear relationship between the concentrations of tinidazole in blend gel and their peak areas in the ranges of 5~ 500 mg/L. The regression reactionwasy=0·836+8·452 2×10-5x(r=0·998 6). RSDwas 0·2%.③Polylactic acid had no influence on the determination of tinidazole. The daily average release of tinidazole was 5·60%.The cumulative release of tini- dazole was about 78·40% in 14 days.Conclusion Thein vitrodrug release analysis is an useful method in evaluating the per- formance of local drug delivery system. HPLC analysis is a simple and accurate method with good reproducibility.
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