格拉司琼透皮贴剂的质量控制研究

On Quality Control of Granisetron Transdermal Patch

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。

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.