目的 考察茵陈蒿汤基准样品的制备工艺。方法 建立HPLC同时测定茵陈蒿汤中绿原酸、1-咖啡酰奎宁酸（1-caffeoylquinic acid，1-CQA）、栀子苷、山栀苷、京尼平龙胆双糖苷（genipin gentiobioside，GG）、西红花苷I、西红花苷II、jasminoside B、芦荟大黄素-8-O-葡萄糖苷（aloe emodin-8-O-glucopyranoside，AE8G）、大黄酸-8-O-葡萄糖苷（rhein-8-O-glucoside，R8G）和没食子酸11个成分含量的方法，以这11个成分提取量或转移率为指标，分别进行茵陈蒿汤基准样品制备的煎煮方法、加水量、煎煮时间、煎煮次数、浓缩温度单因素考察，以加水量、煎煮时间、浓缩温度为考察因素，采用正交试验法对单因素考察设定的2个水平进行优化组合，并对优化的工艺进行放大验证试验。结果 单因素考察显示，6个、9个、10个成分的提取量分别为同煎、加茵陈18倍和15倍水、煎煮30 min和20 min优于先煎茵陈、加茵陈12倍和10倍水、煎煮60 min和40 min（P＜0.05、0.01）；与提取3次的提取总量相比，前2煎各成分的提取量占比均接近或超过70%，2个成分的转移率50 ℃减压浓缩明显高于80 ℃减压浓缩（P＜0.01）。正交试验优选的茵陈蒿汤基准样品制备工艺为3味药同煎2次，加水量分别为18倍和15倍，煎煮时间分别为30 min和20 min，50 ℃减压浓缩。放大10倍的验证试验结果与小试结果一致。结论 优选的工艺稳定、简单、重复性好，可用于经典名方茵陈蒿汤基准样品的制备。

Objective To investigate the preparation process of the benchmark sample of Yinchenhao Decoction (YD, 茵陈蒿汤). Methods An HPLC method was established to simultaneous determine the content of 11 components in YD, including chlorogenic acid, 1-caffeoylquinic acid (1-CQA), geniposide, shanzhiside, genipin gentiobioside (GG), crocin I, crocin II, jasminoside B, aloe emodin-8-O-glucopyranoside (AE8G), rhein-8-O-glucoside (R8G) and gallic acid. Using the extraction amount or transfer rate of these 11 components as indicators, single factor investigations were conducted on the preparation of benchmark sample of YD, including the decocting methods, quantity of water addition, decoction time, decoction times, and concentration temperature. Taking the quantity of water addition, decoction time, and concentration temperature as the evaluation factors, the two levels set for the single factor investigations mentioned above were optimized and combined by the orthogonal experimental method, and the optimized process was verified through amplification experiments. Results The single-factor investigation indicated that the extraction amounts of six, nine, and 10 components were higher under the conditions of co-decoction, decocting with 18-fold and 15-fold water for 30 min and 20 min, respectively, compared to the conditions of pre-decocting Yinchen (Artemisiae Scopariae Herba) followed by decocting with 12-fold and 10-fold water for 60 min and 40 min (P < 0.05, 0.01). Compared with the total amount extracted three times, the extraction amount of each component in the first two decoctions were all close to or exceeded 70%. The transfer rates of two components were significantly higher under reduced-pressure concentration at 50  ℃ than at 80  ℃ (P < 0.01). The optimal preparation process using orthogonal experiment for the benchmark sample of YD was as follows: decocting the three herbs together twice, with 18-fold and 15-fold volume water, for 30 and 20 min, respectively, then concentrating at 50 ℃ under reduced pressure. The results of the validation experiment magnified by 10 was consistent with lab-scale results. Conclusion The optimized process is stable, simple, and repeatable, which can be used for the preparation of substance benchmark of classical prescription YD.

R283.6

江苏省重点研发计划（社会发展）项目（BE2018674）；江苏省药学会—奥赛康医院药学基金科研课题（A202330）