目的 建立经典名方身痛逐瘀汤（Shentong Zhuyu Decoction，SZD）基准样品的UPLC指纹图谱及7指标成分含量测定方法，明确关键质量属性的传递规律。方法 通过制备15批SZD基准样品，以指纹图谱、指标成分含量及出膏率为评价指标，结合多批次含量转移率范围，单味药与基准样品色谱峰相对峰面积和出膏率进行饮片-基准样品量值传递规律分析，阐明SZD基准样品关键质量属性。结果 采用UPLC建立指纹图谱方法重现性良好，15批基准样品相似度均大于0.90，共确定15个特征峰，通过与对照品比对指认了其中9个成分，其中秦艽、川芎、桃仁、红花、甘草、羌活、没药、当归、醋五灵脂9味药在指纹图谱中均有体现；基准样品中指标成分苦杏仁苷质量分数为0.306%～0.548%，甘草酸质量分数为0.179%～0.429%，马钱苷酸质量分数为0.106%～0.349%，龙胆苦苷质量分数为0.283%～0.695%，羟基红花黄色素A质量分数为0.129%～0.592%，阿魏酸质量分数为0.036%～0.069%，洋川芎内酯I质量分数为0.024%～0.046%；饮片至水煎液平均转移率分别为36.49%、47.46%、83.34%、72.07%、66.02%、61.35%、62.74%，水煎液-基准样品平均转移率分别为88.26%、89.47%、88.28%、90.22%、84.22%、91.00%、87.84%；15批基准样品出膏率为27.52%～32.26%。结论 初步构建SZD基准样品质量评价方法，为SZD基准样品的质量控制和复方制剂开发提供科学依据。

Objective To establish the UPLC profiles and methods for detecting the index components in benchmark sample of the classical prescription Shentong Zhuyu Decoction (SZD, 身痛逐瘀汤), and clarify the transmission law of key quality attributes. Methods By preparing 15 batches of substance benchmarks for SZD, was established evaluation indexes of fingerprint, index component content and extraction rate, In conjunction with the range of multi-batch content transfer rate, the relative peak area of chromatographic peaks for single drugs and substance benchmarks samples, as well as their extract rates, these parameters were determined to define the key quality attributes of substance benchmarks of SZD. Results The results demonstrate that the method of UPLC fingerprint exhibits excellent reproducibility, with a similarity exceeding 0.90 among the fingerprints of 15 batches of substance benchmark samples. Fiveteen characteristic peaks were identified, of which nine characteristic peaks were assigned by the reference substance. These fingerprints reflect the presence of nine herbal components: Qinjiao (Gentianae Macrophyllae Radix), Chuanxiong (Chuanxiong Rhizoma), Taoren (Persicae Semen), Honghua (Carthami Flos), Gancao (Glycyrrhizae Radix et Rhizoma), Qianghuo (Notopterygii Rhizoma et Radix), Moyao (Myrrha), Danggui (Angelicae Sinensis Radix), Cuwulingzhi (vinegar-processed Trogopterori Faeces). The mass fraction of the seven components in the benchmark samples were respectively: amygdalin 0.306%—0.548%, glycyrrhizic acid 0.179%—0.429%, loganic acid 0.106%—0.349%, gentiopicrin 0.283%—0.695%, hydroxysafflor yellow A 0.129%—0.592%, ferulic acid 0.036%—0.069%, senkyunolide I 0.024%—0.046%. The average transfer rates of decoction pieces to decoction were 36.49%, 47.46%, 83.34%, 72.07%, 66.02%, 61.35%, 62.74%. The average transfer rates from decoction pieces to benchmark sample were 88.26%, 89.47%, 88.28%, 90.22%, 84.22%, 91.00%, 87.84%. The extraction rate of the substance reference of the 15 batches were 27.52%—32.26%. Conclusion This study preliminarily established a quality evaluation method of SZD was preliminarily established to provide scientific basis for the quality control of substance standards and the development of compound preparations.

国家工信部2022年产业技术基础公共服务平台项目——中药全产业链质量技术服务平台（2022-230-221）