跌打片质量标准提高研究

Study on the Quality Standard of Dieda Tablets

目的建立跌打片成分定性、定量分析方法以提高其质量标准。方法采用薄层色谱（TLC）法，建立跌打片中三七、续断、血竭、白芍、赤芍、牡丹皮、枳实和骨碎补的定性分析方法；采用高效液相色谱（HPLC）法测定川续断皂苷Ⅵ的含量，色谱柱为Kromasil^TM C18柱（150mm×4．6mm，5μm），流动相为乙腈-水（梯度洗脱），流速1．0mL／min，检测波长212nm，柱温35℃。结果TLC鉴定组成斑点清晰，阴性无干扰；川续断皂苷Ⅵ进样量在0．3473～2．4308μg范围内与峰面积呈良好的线性关系（r=0．9999），平均加样回收率为99．14％，RSD为1．34％（n=9）。结论该法准确可靠、专属性强、重复性好，能有效地控制跌打片的内在质量。

Objective To establish the qualitative and quantitative methods to improve its quality standard of Dieda Tablets. Methods TLC was applied to the identification of Notoginseng Radix et Rhizoma, Dipsaci Radix, Draconis Sanguis, Paeonia Radix Alba, Paeonia Radix Rubra, Moutan cortex, Aurantii Fructus ImmaTurus and Drynaria Rhizoma; HPLC was applied to determinte asperosaponin VI; the analytical column was Kromasil^TM C18 column（150 mm ×4.6 mm, 5 μm）; the mobile phase was acetonitrile-water at the flow rate of 1.0 mL/min; the detection wavelength was 212 nm; and the column temperature was 35 ℃. Results The spots in the TLC were clear and could be well separated, the blank test showed that other medicine herbs had not interference with the main one; The calibration curve of asperosaponin VI showed good linearity in the range of 0. 347 3-2. 430 8 μg（ r=0. 999 9）. The average recovery was 99. 14%, RSD was 1.34% （ n = 9）. Conclusion The established methods are accurate, reliable, specific and with good reproducibility. It can be used for the quality control of the Dieda Tablets.