CAJ | 학술논문

目的：建立格拉司琼透皮贴剂的质量控制方法。方法采用高效液相色谱法测定贴剂中主药的含量、体外释放度,并以剥离强度、初黏力和持黏力为指标考察贴剂的黏附性。结果贴剂中格拉司琼的含量限度为(100±10)%；在2,6,10 h内的释放度分别为30%~35%、65%~75%和80%~85%；三批样品试验结果表明：该贴剂具有良好的黏附性。结论检测方法科学、合理,为格拉司琼透皮贴剂的质量控制提供了可靠依据。
목적：건립격랍사경투피첩제적질량공제방법。방법채용고효액상색보법측정첩제중주약적함량、체외석방도,병이박리강도、초점력화지점력위지표고찰첩제적점부성。결과첩제중격랍사경적함량한도위(100±10)%；재2,6,10 h내적석방도분별위30%~35%、65%~75%화80%~85%；삼비양품시험결과표명：해첩제구유량호적점부성。결론검측방법과학、합리,위격랍사경투피첩제적질량공제제공료가고의거。
Objective To establish methods for the quality control of granisetron transdermal patch. Method The content and release rate of granisetron in the patch were determined by HPLC, and the tack strength, shear strength, peel strength were tested as adhesive indexes. Results The content limitation of granisetron in the patch was (100 ± 10)%;the release rates were 30% ~35%,65% ~75% and 80% ~85% at 2,6 and 10 h in vitro, respectively. The results of 3 batches of samples showed that the patch had good adhesiveness. Conclusion The detection methods are scientific,reasonable,and can provide references for the quality control of granisetron transdermal patch.