舒味咀嚼片的质量标准研究

Study on Quality Standard of Shuwei Chewable Tablets

通过薄层色谱法(TLC)分别建立了舒味咀嚼片中太子参、白术药味的定性鉴别机制。应用高效液相色谱法(HPLC)对舒味咀嚼片中标志性的成分橙皮苷进行了定量检测。通过方法学验证,橙皮苷测定质量浓度线性范围为40.60~202.99μg/mL(r=0.9999),精密度、重复性、稳定性试验的RSD均<2%(n=6),平均加样回收率为97.61%,RSD为0.7%(n=6)。因此,建立的质量标准简便、可靠,重复性好,适用于舒味咀嚼片的质量控制。

TLC was used for qualitative identification of Pseudostellaria heterophylla,Atractylodes macrocephala in the Shuwei Chewable Tablets.HPLC method was used to determine the content of hesperidin.Accord to methodology validation,The linear range of hesperidin was 40.60μg/mL^202.99μg/mL(r=0.9999).RSDs of precision,stability and reproducibility tests were lower than 2%.The average recovery was 97.61%with RSD of 0.7%(n=6).Established quality standard of Shuwei chewable tablets is simple,reliable and repeatability,and be used for the quality evaluation of Shuwei chewable tablets.