盐酸利多卡因缓释膜的体外释放度测定

Determination of in vitro release of lidocaine hydrochloride sustained release film

目的测定盐酸利多卡因缓释膜的质量分数及体外释放度。方法采用超高效液相色谱法（UPLC）对膜剂中的盐酸利多卡因进行快速测定;参照2010年版《中国药典》附录ⅩD第三法,采用改良的桨碟法进行释放度试验。结果 UPLC法对盐酸利多卡因的测定准确度和精密度良好,辅料不干扰药物的测定,平均回收率为99.55%,RSD为0.40%;盐酸利多卡因在20.15~503.8μg/m L范围内线性关系良好;3批自制盐酸利多卡因缓释膜24 h的累积释放率接近100%,符合一级释药模型。结论所建立的释放度测定方法准确可行,可用于该制剂的质量控制。

Objective To determine the content and release rate of lidocaine hydrochloride sustained release film. Methods Lidocaine hydrochloride in the membrane was rapidly determined by ultra-performance liquid chromatography（ UPLC）. The release degree test was carried out by using the modified method in accordance with the third method of Chinese Pharmacopoeia 2010 edition [Appendix ⅩD the law]. Result The accuracy and precision of UPLC for the determination of lidocaine hydrochloride were good,which was not interference with the accessories. The recovery rate was 99.55%,the RSD was 0.40%. The linearity was good in the range of 20. 15- 503. 8 μg/m L of lidocaine hydrochloride. The cumulative release rate of 3batches was close to 100% in 24 hours. The release rate profiles were in accord with the first-order release model. Conclusion The method established for release test can be used for the quality control.