复方九节茶乳膏的质量标准研究

Quality standard of compound Sarcandra Glabra ointment

目的建立复方九节茶乳膏质量标准.方法采用薄层色谱法对九节茶和冰片进行鉴别;HPLC双波长法测定复方九节茶乳膏中反丁烯二酸与迷迭香酸含量.采用KromasilC18色谱柱（250mm×4.6mm,5μm）,流动相为0.1%甲酸乙腈溶液（B）-0.1%甲酸水溶液（D）,梯度洗脱[0～10min,5% B→20% B;10～25min,20% B;25～30min,20% B→5% B;30～35min,5% B],流速为1.0mL·min^-1,检测波长为210nm和330nm,柱温为30℃.结果薄层鉴别斑点清晰,阴性无干扰;反丁烯二酸和迷迭香酸线性范围分别为6.53～65.28mg·L^-1（r=0.9999）和4.26～42.64mg·L^-1（r=0.9995）;平均加样回收率分别为98.3%（RSD=0.82%）和100.9%（RSD=0.63%）.结论该方法简单、准确、重复性好,能有效的控制该制剂的质量.

Objective To establish the quality standard for compound Sarcandra Glabra ointment.Methods Sarcandra Glabra and synthetic borneol in the formula were identified qualitatively by TLC and the contents of fumaric acid and rosmarinci acid were deter-mined by HPLC.An Kromasil C18 column(250 mm ×4.6 mm,5μm)was adopted at 30℃.The mobile phases were 0.1% formic acid acetonitrile solution (B)and 0.1% formic acid water solution(D)with a gradient elution mode(0 ~10 min,5%B→20% B;10 ~25 min,20% B;25 ~30 min,20% B→5% B;30 ~35 min,5% B)at the flow rate of 1.0 mL·min -1 .And the detection wavelength was 210 nm and 330 nm.Results Sarcandra Glabra and synthetic borneol could be detected by TLC.Fumaric acid and rosmarinci acid were well separated within a linear range of 6.53 ~65.28(r =0.999 9)and 4.26 ~42.64 mg·L -1 (r =0.999 5),respectively.The average recoveries were 98.3% with RSD 0.82%,100.9% with RSD 0.63%,respectively.Conclusions The method was accurate, sensitive and reproducible,which can be used for its quality control.