亚麻木酚素缓释片的质量标准研究

Study on the Quality Specification of Secoisolariciresinol Diglucoside Sustained-release Tablets

目的：为建立亚麻木酚素缓释片的质量标准提供参考。方法：采用高效液相色谱法测定亚麻木酚素缓释片的含量,并测定其体外释放度。色谱柱为Waters Symmetny Shield-C18,流动相为甲醇-水（35∶65,V/V）,流速为1.0 ml/min,检测波长为282 nm,柱温为室温,进样量为10μl。结果：亚麻木酚素的质量浓度在0.018~0.225 mg/ml范围内与峰面积呈良好的线性关系（r=0.999 5）;精密度、稳定性、重复性试验的RSD〈2%;平均加样回收率为99.59%,RSD=1.95%（n=6）。亚麻木酚素缓释片在2、6、12 h的累积释放度分别为10%~30%、50%~70%、80%~100%,均符合规定。结论：该方法准确、简便,专属性、重复性好,可用于亚麻木酚素缓释片的质量控制。

OBJECTIVE：To provide reference to establish the quality specification of Secoisolariciresinol diglucoside（SDG）sustained-release tablets. METHODS：The content of SDG sustained-release tablets was determined by HPLC and the release property was studied in vitro. HPLC conditions were as follows：Waters Symmetny Shield-C18 column,methanol-water（35∶65,V/V）as mobile phase at a flow rate of 1.0 ml/min. The detection wavelength was 282 nm,the column temperature was room temperature and injection volume was 10 μl. RESULTS：The concentration of SDG had a good linear relationship with its peak area value in the range of 0.018~0.225 mg/ml（r=0.999 5）. The RSDs of precision,stability and reputability test were less than 2%;the average sample recovery were 99.59%,RSD=1.95%（n=6）. The accumulative release amount of SDG sustained-release tablets in 2,6,12 h were 10%-30%,50%-70% and 80%-100%,respectively,which conform to the provisions. CONCLUSIONS：The method is accurate,simple,specificity and reproducible,and can be used for the quality control of SDG sustained-release tablets.