北方药学
北方藥學
북방약학
JOURNAL OF NORTH PHARMACY
2014年
3期
80-81
,共2页
肖学成%张磊%彭秀菊%熊驰
肖學成%張磊%彭秀菊%熊馳
초학성%장뢰%팽수국%웅치
0.1％他克莫司软膏%体外透皮吸收%高效液相色谱法
0.1％他剋莫司軟膏%體外透皮吸收%高效液相色譜法
0.1％타극막사연고%체외투피흡수%고효액상색보법
0.1％Tacrolimus%Ointment%Percutaneous absorption%HPLC
目的：建立0.1%他克莫司软膏体外透皮接收液中药物的HPLC测定方法，研究0.1%他克莫司软膏的体外透皮量。方法：采用Kromasil 100-5 C18色谱柱（250mm×4.6mm，5μm）；流动相：乙腈-水-磷酸（690∶310∶1）；流速：1.0ml/min；检测波长：215nm。体外透皮实验采用自制改良的Franz直立式扩散池，使用实验用离体乳猪皮作为透皮屏障。将自制凝胶与市售凝胶的透皮结果进行对比分析，分别在设定的1h、2h、4h、6h、8h、12h时间点取样测定透皮接收液中他克莫司的浓度，计算累积透皮量。结果：他克莫司的标准曲线方程为A=17408.1203×C+555.4604（r=0.9995），线性范围为2.036～20.36μg/ml，平均回收率为99.15%。结果表明，累积透皮量与时间呈现良好的线性关系，自制乳膏与市售乳膏的透皮结果无显著性差异（P＞0.05）。结论：本检测方法操作简便，快速准确，是考察他克莫司软膏的体外透皮性能比较理想的方法。
目的：建立0.1%他剋莫司軟膏體外透皮接收液中藥物的HPLC測定方法，研究0.1%他剋莫司軟膏的體外透皮量。方法：採用Kromasil 100-5 C18色譜柱（250mm×4.6mm，5μm）；流動相：乙腈-水-燐痠（690∶310∶1）；流速：1.0ml/min；檢測波長：215nm。體外透皮實驗採用自製改良的Franz直立式擴散池，使用實驗用離體乳豬皮作為透皮屏障。將自製凝膠與市售凝膠的透皮結果進行對比分析，分彆在設定的1h、2h、4h、6h、8h、12h時間點取樣測定透皮接收液中他剋莫司的濃度，計算纍積透皮量。結果：他剋莫司的標準麯線方程為A=17408.1203×C+555.4604（r=0.9995），線性範圍為2.036～20.36μg/ml，平均迴收率為99.15%。結果錶明，纍積透皮量與時間呈現良好的線性關繫，自製乳膏與市售乳膏的透皮結果無顯著性差異（P＞0.05）。結論：本檢測方法操作簡便，快速準確，是攷察他剋莫司軟膏的體外透皮性能比較理想的方法。
목적：건립0.1%타극막사연고체외투피접수액중약물적HPLC측정방법，연구0.1%타극막사연고적체외투피량。방법：채용Kromasil 100-5 C18색보주（250mm×4.6mm，5μm）；류동상：을정-수-린산（690∶310∶1）；류속：1.0ml/min；검측파장：215nm。체외투피실험채용자제개량적Franz직입식확산지，사용실험용리체유저피작위투피병장。장자제응효여시수응효적투피결과진행대비분석，분별재설정적1h、2h、4h、6h、8h、12h시간점취양측정투피접수액중타극막사적농도，계산루적투피량。결과：타극막사적표준곡선방정위A=17408.1203×C+555.4604（r=0.9995），선성범위위2.036～20.36μg/ml，평균회수솔위99.15%。결과표명，루적투피량여시간정현량호적선성관계，자제유고여시수유고적투피결과무현저성차이（P＞0.05）。결론：본검측방법조작간편，쾌속준학，시고찰타극막사연고적체외투피성능비교이상적방법。
Objective:To establish an HPLC method for quantitative the determination of tacrolimus in vitro percutaneous solution,and investigate the ability of percutaneous penetration of 0.1% tacrolimus ointment. Methods:Kromasil 100-5 C18 column (250mm × 4.6mm,5μm)was used as the fixed phase and a mixture of acetonitrile,purified water and phosphoric acid (690∶310∶1) as mobile phase.The flow rate was 1.0 ml/min.The detection wavelength was 215nm.Improved Franz type diffusion cells were used in vitro permeation studies and excised minipigs skins in vitro were used as transdermal barrier.The concentration of 0.1% tacrolimus ointment in the receptor solution was determined by HPLC to investigate its cumulative permeation quantities at different time respectively and compared with that of the commercial ointment. Results:The regression equation of tacrolimus ointment was linear in the range of 2.036~20.36μg/ml A=17408.1203×C+555.4604 (r=0.9995).The average recovery was 99.15%.A good linear relationship existed between the cumulative penetration quantities and the time.There was no significant difference in the permeation quantities between the self-made and commercial ointment. Conclusion:The method was simple, rapid, and accurate. It is a good method to evaluate the characteristic of permeation for tacrolimus ointment.
