目的 制备熟地黄饮片标准汤剂，并建立其质量标准。方法 以水为提取溶剂，参照标准化工艺制备了15批不同产地的熟地黄的标准汤剂，测定毛蕊花糖苷，计算出膏率，并建立其HPLC指纹图谱分析方法。结果 熟地黄标准汤剂中毛蕊花糖苷的质量浓度为0.011~0.025 mg/mL，出膏率为40.19%~60.79%。指纹图谱包含10个共有峰，通过对照品指认了2个，分别是5-羟甲基糠醛和毛蕊花糖苷，对熟地黄标准汤剂指纹图谱的相似度进行评价，其相似度均大于0.9。结论 本法简便，精密度高，重复性好，可用于熟地黄标准汤剂的质量标准研究，为熟地黄配方颗粒的质量控制提供参考。

Objective To prepare standard decoction of Rehmanniae Radix Praeparata and establish quality standard.Methods The 15 batches of Rehmanniae Radix Praeparata from various of habits were extracted with water according to the standardization process, and the contents of acteoside were determined, then its extract rates were calculated, and the analysis method of HPLC fingerprint was set up. Results The contents of acteoside in standard decoction of Rehmanniae Radix Praeparata were 0.011-0.025 mg/mL, and the extraction ratios ranged from 40.19% to 61.79%. The fingerprint contained 10 common peaks, and two of them were identified with standard substance, including 5-hydroxymethyl furfural and acteoside. The similarities of the fingerprint for the standard decoction of Radix rehmanniae Praeparata were analyzed and evaluated, and the similarities were more than 0.9. Conclusion This method is simple, accurate and reproducible, which can be applied to quality standard research on standard decoction of Rehmanniae Radix Praeparata and provide reference for the quality control of dispensing granules of Rehmanniae Radix Praeparata.

国家科技重大专项重大新药创制项目（2011ZX09201-201-15）