知柏地黄胶囊质量标准研究

Study on Quality Standard for Zhibai Dihuang Capsules

目的：提高知柏地黄胶囊的质量标准。方法：采用TLC法对处方中山茱萸和熟地黄进行定性鉴别；采用HPLC法同时测定山茱萸中莫诺苷、马钱苷及牡丹皮中丹皮酚的含量。结果：TLC定性鉴别重复性好，阴性无干扰；莫诺苷、马钱苷和丹皮酚的线性范围分别为0．05～1．11μg（r＝0．9999）、0．07～1．52μg（r＝0．9999）、0．09～1．96μg（r＝0．9999）；平均回收率（n＝6）分别为101．6％、102．5％、103．4％，其RSD分别为2．2％、1．4％、1．1％。结论：该方法操作简便、准确，重复性好，可用于知柏地黄胶囊的质量控制。

Objective：To improve the quality standard of Zhibai Dihuang Capsules .Methods：Corni Fructus and Rehmanniae Radix Praeparata were identified by TLC , the contents of morroniside , loganin and paeonol were determined by HPLC .Results： The TLC methods were specific and reproducible .The linear ranges of morroniside, loganin and paeonol were 0.05-1.11 μg（r=0.999 9）, 0.07-1.52 μg（r=0.999 9）and 0.09-1.96 μg（r=0.999 9）, respectively.The recoveries（n=6）of morroniside, loganin and pae-onol were 101.6%,102.5%and 103.4%, respectively.RSD were 2.2%,1.4%and 1.1%, respectively.Conclusion：The methods are simple,accurate and reproducible for the quality control of Zhibai Dihuang Capsules .