益心酮渗透泵控释片的制备和含量测定

目的：制备益心酮渗透泵控释片并建立其含量测定方法.方法：应用双层压片技术和激光致孔法制备益心酮渗透泵控释片;采用Yilite C18色谱柱（250 mm×215;4.6 mm,5 μm）,流动相为四氢呋喃-甲醇-乙腈-0.5%醋酸溶液（19.4：1：1：78.6）,检测波长为363 nm,流速为1.0 ml·ml^-1,柱温为30℃,进样量20 μl.结果：制得的益心酮渗透泵控释片质量稳定;在上述色谱条件下,金丝桃苷浓度在2.0～8.4 μg·ml^-1之间线性良好,r=0.999 9,平均加样回收率为101.0%,RSD为0.95%（n=6）.结论：益心酮渗透泵控释片制备方法可行,高效液相色谱含量测定方法快速灵敏,结果准确可靠,可用于益心酮渗透泵控释片的质量控制.

Preparation and Determination of Yixintong Osmotic Pump Controlled Release Tablets

Objective： To prepare Yixintong osmotic pump controlled release tablets and establish a method for the determination. Methods： Yixintong osmotic pump controlled release tablets were developed using double-layer compressing technique and laser- punched system. The HPLC method was performed on a Yilite Cls column （250 mm × 4.6 mm, 5μm） at the temperature of 30℃. The mobile phase consisted of tetrahydrofuran-methanol-acetonitrile-0.5% acetic acid （ 19. 4： 1 ： 1 ： 78.6 ）. The detection wavelength was at 363nm, the flow rate was 1.0 ml·ml^-1, and the sample size was 20 μl. Results： The quality of Yixintong osmotic pump con- trolled release tablets was stable. Under the chromatographic conditions, the relationship between the concentration and the peak area of hyperoside was in a good linearity within the range of 2.0 -8.4 ·ml^-1 （ r = 0. 999 9 ）. The average recovery of hyperoside was 101.0% （RSD = 0.95%, n = 6）. Conclusion： It is feasible to prepare Yixintong osmotic pump controlled release tablets. The HPLC method is simple, rapid and accurate.