【摘要】 目的建立盐酸替扎尼定口腔崩解片溶出度的测定方法。方法依照《中国药典》2000年版附录溶出度测定项下第一法,以水为溶出介质,转速为100 r.min-1,用HPLC法检测,检测波长为320 nm。结果在1~10μg.ml-1范围内,盐酸替扎尼定浓度与峰面积的线性关系良好(r=0.9999),高、中、低3种浓度的平均加样回收率为99.0%~99.4%,RSD为0.12%~0.15%;6批口腔崩解片样品的溶出度为92.0%~104.0%。结论所建方法操作简便、准确、可靠,适用于盐酸替扎尼定口腔崩解片的质量控制。更多还原

【Abstract】 OBJECTIVE To establish a method for determination of the dissolution of Tizanidine hydrochloride orallydisintegrating tablet.METHODS Dissolution test was carried out,with distilled water as solvents,rotation speed of 100 r·min^-1 and determination of HPLC at 320 nm.RESULTS There was good linear relationship between Tizanidine hydrochloride and peak area within the range of 1～10 μg·ml^-1（r=0.9999）,with average recovery from 99.0% to 99.4% at three different levels and RSD from 0.12% to 0.15%.The dissolution of six batches was from 92.0% to 104%.CONCLUSION This method is simple,quick,accurate and suitable for the quality control of Tiazanidine hydrochloride orallydisintegrating tablets.更多还原