目的 建立經(jīng)典名方身痛逐瘀湯（Shentong Zhuyu Decoction，SZD）基準樣品的UPLC指紋圖譜及7指標成分含量測定方法，明確關(guān)鍵質(zhì)量屬性的傳遞規(guī)律。方法 通過制備15批SZD基準樣品，以指紋圖譜、指標成分含量及出膏率為評價指標，結(jié)合多批次含量轉(zhuǎn)移率范圍，單味藥與基準樣品色譜峰相對峰面積和出膏率進行飲片-基準樣品量值傳遞規(guī)律分析，闡明SZD基準樣品關(guān)鍵質(zhì)量屬性。結(jié)果 采用UPLC建立指紋圖譜方法重現(xiàn)性良好，15批基準樣品相似度均大于0.90，共確定15個特征峰，通過與對照品比對指認了其中9個成分，其中秦艽、川芎、桃仁、紅花、甘草、羌活、沒藥、當(dāng)歸、醋五靈脂9味藥在指紋圖譜中均有體現(xiàn)；基準樣品中指標成分苦杏仁苷質(zhì)量分數(shù)為0.306%～0.548%，甘草酸質(zhì)量分數(shù)為0.179%～0.429%，馬錢苷酸質(zhì)量分數(shù)為0.106%～0.349%，龍膽苦苷質(zhì)量分數(shù)為0.283%～0.695%，羥基紅花黃色素A質(zhì)量分數(shù)為0.129%～0.592%，阿魏酸質(zhì)量分數(shù)為0.036%～0.069%，洋川芎內(nèi)酯I質(zhì)量分數(shù)為0.024%～0.046%；飲片至水煎液平均轉(zhuǎn)移率分別為36.49%、47.46%、83.34%、72.07%、66.02%、61.35%、62.74%，水煎液-基準樣品平均轉(zhuǎn)移率分別為88.26%、89.47%、88.28%、90.22%、84.22%、91.00%、87.84%；15批基準樣品出膏率為27.52%～32.26%。結(jié)論 初步構(gòu)建SZD基準樣品質(zhì)量評價方法，為SZD基準樣品的質(zhì)量控制和復(fù)方制劑開發(fā)提供科學(xué)依據(jù)。

Objective To establish the UPLC profiles and methods for detecting the index components in benchmark sample of the classical prescription Shentong Zhuyu Decoction (SZD, 身痛逐瘀湯), 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.

國家工信部2022年產(chǎn)業(yè)技術(shù)基礎(chǔ)公共服務(wù)平臺項目——中藥全產(chǎn)業(yè)鏈質(zhì)量技術(shù)服務(wù)平臺（2022-230-221）