目的 建立以2-异丁基苹果酸葡萄糖氧基苄酯类对照提取物为对照的白及质量控制方法。方法 采用ZORBAX Eclipse Plus C₁₈（100 mm×2.1 mm，1.8 μm）色谱柱，流动相为0.05%磷酸水溶液（A）-乙腈（B），梯度洗脱，柱温35℃，体积流量0.15 mL/min，进样体积为2 μL，检测波长为220 nm。分别采用对照品法和对照提取物法测定17批白及饮片中1,4-二[4-(葡萄糖氧)苄基]-2-异丁基苹果酸酯-2-葡萄糖苷（2-O-葡萄糖基白及苷）、1-[4-(葡萄糖氧)苄基]-2-异丁基苹果酸酯（手参苷Ⅰ）、1,4-二[4-(葡萄糖氧)苄基]-2-异丁基苹果酸-2-(6-O-乙酰基)葡萄糖苷（手参苷Ⅲ）、1,4-二[4-(葡萄糖氧)苄基]-2-异丁基苹果酸酯（白及苷）4个成分的含量，并进行比较。结果 2-异丁基苹果酸葡萄糖氧基苄酯类对照提取物中2-O-葡萄糖基白及苷、手参苷Ⅰ、手参苷Ⅲ、白及苷线性关系良好（r≥0.999 9），进样精密度RSD值在0.001%～0.58%，重复性RSD值在0.27%～0.53%，4种成分的加样回收率在98.42%～101.53%，样品溶液在24 h内各成分稳定性良好。两种方法测定结果进行t检验，P＞0.05，说明两种方法无显著差异，两种检测方法结果具备一致性。结论 验证了2-异丁基苹果酸葡萄糖氧基苄酯类对照提取物可代替单体对照品的可行性，可应用于白及及其制剂的质量控制研究。

Objective To establish of a quality control method for Bletilla striata with glucosyloxybenzyl 2-isobutylmalates reference extract as a control. Methods A ZORBAX Eclipse Plus C₁₈ (100 mm×2.1 mm, 1.8 μm) column was used with the mobile phase of 0.05% phosphoric acid aqueous solution (A)-acetonitrile (B), gradient elution, column temperature of 35 ^oC, flow rate of 0.15 mL/min, injection volume of 2 μL, detection wavelength of 220 nm. The contents of dactylorhin A, gymnoside I, gymnoside III and militarine in 17 batches of B. striata tablets were determined by the control method and the control extract method, respectively, and compared. Results The linearity of dactylorhin A, gymnoside I, gymnoside III and militarine in the reference extract of glucosyloxybenzyl 2-isobutylmalates was good (r≥0.999 9), the precision of the injection RSD values were in the range of 0.001%-0.58%, the reproducibility RSD values were in the range of 0.27%-0.53%. The recoveries of the four components ranged from 98.42% to 101.53%, and the stability of the sample solutions was good within 24 h. The results of the two methods were determined by t-test, P＞0.05, indicating that there was no significant difference between the two methods and the results of the two assays were consistent. Conclusion This study verified the feasibility of glucosyloxybenzyl 2-isobutylmalates reference extract as a substitute for the monomeric control, which can be applied to quality control studies of B. striata and its preparations.

R286.12

国家自然科学基金项目（U1812403）；贵州省科技计划项目（黔科合基础[2019]1027号）；国家公益性行业科研专项经费项目（201507002）