复方鳖甲软肝片的质量控制研究

目的：对复方鳖甲软肝片的质量控制方法进行研究。方法：采用TLC法对板蓝根、芍药苷进行鉴别；黄芪甲苷采用高效液相色谱-蒸发光散射检测，阿魏酸采用高效液相色谱法。结果：复方鳖甲软肝片的主要有效成分与相应的对照品均有相同的鉴别反应；黄芪甲苷在1．4211．7mg·g^-1呈良好的线性关系（r=0．9994），平均回收率99．6％。阿魏酸在0．04—0．24mg·g^-1范围内线性关系良好。（r=0．9996），平均回收率97．98％。结论：该制剂制备方法简便，稳定性强。TLC鉴别专属性强，HPLC定量结果准确、重现性好、所建标准可用于复方鳖甲软肝片的质量控制。

Studies on Quality Control of Fufangbiejiaruangan Tablets

Objective：To prepare gynecological Fufangbiejiaruanganpian and establish its Quality standard. Methods： The Paeoniflorin was identified by TLC ; HPLC - ELSD was used to the contents of astragaloside and HPLC was used to assay ferulic acid. Results： Both the chief components in Fufangbiejiaruanganpian and the corresponding reference substances showed the identical discrimination reactions. The good linear correlation of astragaloside was observed from 1.4ug to 11. Tug （ r = 0. 9994） and that of ferulic acid was observed from 0. 04ug to 0. 24ug（ r = 0. 9996）. Average rate of recovery of astragaloside and ferulie acid were 99. 6% and 97.98%. Conclusion：The methods is sensitive in qualitative reaction, specific in TLC identification,accurate in HPLC quantitation and recurrent. The established standard is applicable for the quality control of Fufangbiejiaruanganpian.