补骨脂酊质量标准的建立

Quality Standard for Psoraleae Fructus Tinctures

目的：建立补骨脂酊的质量标准。方法：采用硅胶G薄层板,以正己烷-醋酸乙酯（8∶2）为展开剂进行TLC鉴别;采用高效液相色谱法（HPLC）法测定有效成分补骨脂素和异补骨脂素的含量,色谱柱为Intersil ODS-3（150 mm×4.6 mm,5μm）,流动相为甲醇-水（45∶55）,流速为1.0 ml·min-1,柱温35℃,检测波长为246 nm。结果：TLC鉴别色谱清晰,阴性对照无干扰;HPLC法测定的补骨脂素在4.88~187.50μg·ml-1浓度范围内线性关系良好（r=0.999 9）,平均加样回收率为102.63%,RSD为0.43%,异补骨脂素检测在4.25~163.20μg·ml-1浓度范围内线性关系良好,平均加样回收率为102.37%,RSD为1.13%（r=0.999 9）。结论：所建立的定性、定量方法简便、准确、可靠、重复性好,可用于补骨脂酊的质量控制。

Objective： To establish a quality control standard for psoraleae fructus tinctures. Methods： The identification was detected by TLC on silica gel G plates with hexane-ethyl acetate（ 8∶ 2） as the developing solvent. An HPLC method was applied in the quantitative determination of psoralen and isopsoralen as the effective components. The analytical column was Intersil ODS-3（ 250 mm× 4. 6 mm,5 μm） with methanol-water（ 45∶ 55） as the mobile phase; the flow rate was 1 ml·min- 1; the detection wavelength was at246 nm and the column temperature was set at 35℃. Results： The characteristic spots for psoralen and isopsoralen were identified by TLC. The concentration of psoralen showed good linearity within the range of 4. 88-187. 50 μg·ml- 1（ r = 0. 999 9） and the average recovery was 102. 63% and RSD was 0. 43%. The concentration of isopsoralen showed good linearity within the range of 4. 25-163. 20 μg·ml- 1（ r = 0. 999 9）,and the average recovery was 102. 37% and RSD was 1. 13%. Conclusion： The qualitative and quantitative methods are simple,accurate,feasible and repeatable,which can be used in the quality control of psoraleae fructus tinctures.