Abstract:

The active ingredient Ligustrum lucidum in Shanxiangyuan was prepared and the quality standard was established based on high performance liquid chromatography （HPLC）. The extraction conditions were optimized according to the yield of Ligustrum lucidum as the index, in which 70% ethanol was used as the solvent under pressure. The results showed that, the optimized extraction process was as follows: The solid-liquid ratio was 1∶30 （g∶mL）; the extraction temperature was 90 ℃; the extraction time was 2.0 h. The optimized purification process was as follows: The flow rate of extraction solvent was 1.0 mL/min; the flow rate of elution solvent was 2.0 BV/h; the elution solvent volume was 2.0 BV/h. In HPLC determination, C₁₈ column （250 mm×4.6 mm, 5 μm） was used, mobile phase A was methanol, phase B was 0.5% phosphoric acid, the flow rate was 1.0 mL/min, the detection wavelength was 360 nm, and the column temperature was room temperature. The results showed that, the linearity was good in the range of 0.309-39.126 μg/mL （r²=0.999 9）, the repeatability was RSD<4.0% （n=6）, the stability （within 24 h） was RSD<2.0% （n=6）, and the average spiked recoveries were 95%-105%. The preparation process of the active ingredients of Shan Xiang Yuan was simple, and the quality standard based on determination by HPLC method was simple, accurate and reproducible, which could provide an experimental basis for the quality control of the content of active ingredients in Shanxiangyuan in future.

Key words: Shanxiangyuan, Ligustrum lucidum, HPLC