摘要
目的：采用HPLC法测定替硝唑-聚癸二酸酐控释制剂的含量，并研究其释药特性。方法：色谱条件为色谱柱：ShimPackVp-ODS柱（250mm×4．6mm，5μm）；柱温：室温；流动相：甲醇-水（20：80）；流速：1mL·min^-1；检测波长：310nm；进样量：10μL。将替硝唑-聚癸二酸酐控释制剂置于0．1mol·L^-1，pH7．4的磷酸缓冲液（PBS）中，37℃恒温振荡，每24h更换一次缓冲液，测定并计算缓冲液中药物浓度及药物累计释放百分率。结果：替硝唑含量在5．0～100．0mg·L^-1范围内，浓度与吸收度之间线性关系良好（r=0．9999）；样品的平均回收率为101．84％，RSD为0．54％（n=4）。释药结果表明，聚癸二酸酐对替硝唑的释放呈一级释放动力学特征，拟合方程：Y=8．0583＋34．4558t-3．1925t^2。结论：该方法灵敏，专属，准确，操作简便，可供该制剂的含量测定。
OBJECTIVE To develop an HPLC method for the determination of tinidazole-poly （sebacic anhydride） controlled-releasing preparations, and study the drug release characteristic. METHODS Chromatographic conditions included column： Shim-Pack VPODS （ 150 mm×4. 6 mm）; column temperature： room temperature; mobilephase： methanol-water（20 ： 80） ; flowrate： 1 mL. min^-1 detector： UV 310 nm; injection volume： 10μL. Tinidazole-Poly（sebacic anhydride） controlled-releasing preparations were put in 0. 1 mol·L^-1, pH 7. 4 PBS, vibrating at 37℃. The buffer was changed once in every 24 h, and was determinated and calculated drug concentration and cumulative release percent. RESULTS The calibration curve was linear （r= 0. 999 9） in the range of 5.0 - 100.0 mg·L^-1 for tinidazole, the mean recovery was 101. 84%, with RSD of 0. 539 40% （n = 4）. The results of drug release demonstrated that the tinidazole-poly （sebacic anhydride） controlled-releasing preparations followed first order release kinetics, the regression equation was Y= 8, 058 33 ＋ 34. 455 83t- 3. 192 5 t^2. CONCLUSION The method is sensitive, specific, accurate, simple and was suitable for the determination of tinidazole preparations.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2006年第7期794-796,共3页
Chinese Journal of Hospital Pharmacy
基金
河北省教育厅基金资助项目(编号:2004423)
关键词
替硝唑
聚癸二酸酐
高效液相法
控释
释药特性
tinidazole
Poly （sebacic anhydride）
HPLC
controlled-releasing
drug release characteristic
