目的 利用HPLC-DAD-ELSD分析技术，建立酸枣仁汤指纹图谱结合多成分含量测定方法，为其质量控制提供参考。方法 采用Phenomenex C₁₈色谱柱（250 mm×4.6 mm，5.0 μm），以0.1%甲酸水溶液-乙腈为流动相进行梯度洗脱，体积流量为1.0 mL/min，柱温30℃，在282 nm和335 nm检测波长下，分别以芒果苷和斯皮诺素为参照峰；ELSD漂移管温度105℃，载气体积流量2.5 L/min条件下，以酸枣仁皂苷A为参照峰，采用中药色谱指纹图谱相似度评价系统对10批自制酸枣仁汤进行相似度评价；同时建立13个指标成分含量测定方法，应用于市售产品及自制样品的质量评价。结果 10批自制酸枣仁汤的平均出膏率为21.57%，在282 nm和335 nm分别标定了5个和4个共有峰，相似度分别为0.907～0.999、0.926～0.999；HPLC-ELSD指纹图谱中标定了4个共有峰，相似度为0.946～0.999。13种指标成分在各自的线性范围内线性关系良好（r＞0.995 9），平均加样回收率为93.69%，RSD值平均为2.04%。10批不同剂型市售产品中新芒果苷、乌药碱、芒果苷、异芒果苷、甘草苷、斯皮诺素、阿魏酸、6'''-阿魏酰斯皮诺素、异甘草苷、知母皂苷BII、酸枣仁皂苷A、酸枣仁皂苷B和甘草酸的质量分数分别为0.30～3.38、0.02～0.20、0.27～6.04、0.33～1.38、1.54～12.02、0.16～0.87、0.16～1.27、0.04～0.35、0.25～3.12、3.66～20.92、0.36～0.98、0.32～0.89、4.90～36.37 mg/g，波动范围大。自制酸枣仁汤13种成分含量波动范围小。结论 建立了酸枣仁汤HPLC-DAD-ELSD指纹图谱与多成分含量测定相结合的质量评价方法，方法准确、可靠，为市售酸枣仁汤产品的质量控制和体内药动学研究提供参考。

Objective To develop the HPLC fingerprint combined with multi-component content determination method to comprehensively evaluate the quality of Suanzaoren Decoction (SZRD). Methods Chromatographic separation was operated at 30℃ on a Phenomenex C₁₈ (250 mm×4.6 mm, 5 μm). The mobile phase consisted of 0.1% formic acid (A) and acetonitrile (B) for gradient elution, and the flow rate was set at 1.0 mL/min. Mangiferin and spinosin were chosen as reference peaks under detection wavelength of 282 nm and 335 nm, respectively. The drift tube of ELSD was set at 105℃ with the nebulizing gas flow rate of 2.5 L/min and jujuboside A as reference peak. Similarity evaluation system for chromatographic fingerprint of TCM was used to evaluate the similarity of 10 batches of SZRD, and a quantitative analysis method of SZRD was established by HPLC-DAD-ELSD and applied to determine 10 batches of SZRD and 10 batches of SZRD commercial products. Results The average yield of 10 batches of SZRD's dry extract was 21.57%. Five and four common peaks were calibrated in HPLC-DAD fingerprint at 282 nm and 335 nm, with their similarity ranged from 0.907 to 0.999, from 0.926 to 0.999, respectively. Four common peaks were calibrated in HPLC-ELSD fingerprint, and the similarity ranged from 0.946 to 0.999. All the calibration curves showed good linearity with correlation coefficients (r) no less than 0.9959, the average recovery was 93.69%, and the average RSD was 2.04%. The content of neomangiferin, coclaurine, mangiferin, isomangiferin, liquiritin, spinosin, ferulic acid, 6'''-feruloylspinosin, isoliquiritin, timosaponin BII, jujuboside A, jujuboside B and glycyrrhizic acid in 10 SZRD commercial products in different dosage forms were 0.30-3.38, 0.02-0.20, 0.27-6.04, 0.33-1.38, 1.54-12.02, 0.16-0.87, 0.16-1.27, 0.04-0.35, 0.25-3.12, 3.66-20.92, 0.36-0.98, 0.32-0.89, 4.90-36.37 mg/g, respectively. Conclusion The results indicated that the new approach was applicable in the routine analysis and quality control of SZRD products. The study might provide a basis for quality control of SZRD, and further pharmacokinetic study of SZRD in vivo.

R286.02

山西省自然科学基金面上项目(20210302123237);山西省自然科学基金面上项目(20210302123470);山西省卫生健康委"十大晋药"项目(ZYCZL 2020007);山西中医药大学青年科学家培育项目(2021PY-QN-07);山西省科学技术厅-地产中药功效物质研究与利用山西省重点实验室项目(201605D111004)