目的: 以四逆散为研究载体, 建立"内标"多控法中药复方质量评价模式, 并对该评价模式进行方法学考察。方法: 选取芍药苷作为四逆散中各成分的参照"内标", 在不同的波长下测定各成分相对于内标成分的校正因子, 利用校正因子和芍药苷对四逆散中柚皮苷、橙皮苷、甘草酸和新橙皮苷进行测定。结果: 芍药苷0.2812-1.6870μg(r=0.9996)、柚皮苷0.5700-3.4200μg(r=0.9994)、橙皮苷0.0502-0.3012μg(r=0.9999)、新橙皮苷0.523-3.1380μg(r=0.9999)、甘草酸铵0.3310-1.9860μg(r=0.9998)与峰面积呈良好线性关系。结论: 建立四逆散中柚皮苷、橙皮苷、甘草酸和新橙皮苷相对于芍药苷的校正因子。比较外标法与"内标"多控法测定的结果, 表明"内标"多控法对中药复方多成分质量控制是可行的、实用的。

Objective: To establish a new quality evaluation method for Chinese compound medicine, using the“internal standard”in Sini Powder reference substance and to calculate multi-components simul taneously．Methods: Relative correction factors (RCF) of naringin, aurantiamarin, neohesperidin, ammo-nium glycyrrhizinate, and a characteristic component peoniflorin as marker, were calcalated in the chro.matographic conditions for the determination of Sini Powder as a research model. The content of peoni-florin was determined by external standard method, and those of naringin, aurantiamarin, neohesperidin, and ammonium glycyrrhizinnate were calculated by RCF compared with peoniflorin. The accuracy of the new method was evaluated by comparing the calculated contents with the determined contents. Results: The linear response ranges of peoniflorin, naringin, aurantiamarin, neohesperidin, and ammonium gly-cyrrhizinate were 0.2812-1.687 tg( r=0．999 6), 0.570 0-3.4200 pg (r=0.9994), 0.050 2-0.3012ug (r=0.9999), 0.0502-0．3012 ug(r=0.9999), 0.5230-3.1380 pg(r=0.9999), 0.3310-1.986ug (r=0.9998). Conclusion: For the first time,“internal standard”multi-control method is adopted in HPLC determination{or five re{erence substances in Sini Powder．The assay demon-strates that the method iS feasible and avalable for the quality control of Sini Powder and it is to be a new quality evaluation pattern for Chinese compound medicines.

国家“十一五”科技支撑计划项目(2006BA108803)