目的 建立苓甘五味姜辛湯基準(zhǔn)樣品的指紋圖譜及其5個(gè)關(guān)鍵指標(biāo)性成分定量測(cè)定方法，研究其基準(zhǔn)樣品量質(zhì)傳遞規(guī)律。方法 采用HPLC法建立苓甘五味姜辛湯指紋圖譜，通過基準(zhǔn)樣品與各單味中藥飲片的相關(guān)性分析進(jìn)行共有峰歸屬，以對(duì)照品進(jìn)行共有峰指認(rèn)，通過各批次間相似度評(píng)價(jià)，分析15批苓甘五味姜辛湯基準(zhǔn)樣品的質(zhì)量差異。同時(shí)建立指標(biāo)性成分甘草苷、甘草酸銨、6-姜酚、五味子醇甲和細(xì)辛脂素定量測(cè)定方法，結(jié)合定量分析結(jié)果及各指標(biāo)成分的轉(zhuǎn)移率進(jìn)行量值傳遞研究。結(jié)果 建立了15批苓甘五味姜辛湯基準(zhǔn)樣品的HPLC指紋圖譜，共標(biāo)定28個(gè)共有峰，各批次間相似度均≥0.950，經(jīng)與對(duì)照品比對(duì)，確定峰7為甘草苷，峰17為甘草酸銨，峰20為6-姜酚，峰22為五味子醇甲，峰26為細(xì)辛脂素。15批苓甘五味姜辛湯基準(zhǔn)樣品中甘草苷、甘草酸銨、6-姜酚、五味子醇甲、細(xì)辛脂素的質(zhì)量分?jǐn)?shù)分別為2.75～4.20、4.38～7.18、0.94～1.69、0.28～0.47、0.21～0.33 mg·g^-1；中藥飲片至基準(zhǔn)樣品的平均轉(zhuǎn)移率分別為21.57%～35.11%、16.83%～31.00%、7.45%～13.64%、3.13%～5.47%、3.15%～5.40%。結(jié)論 建立的指紋圖譜及多指標(biāo)成分定量測(cè)定方法，可用于經(jīng)典名方苓甘五味姜辛湯基準(zhǔn)樣品的量值傳遞分析，為該方劑基準(zhǔn)樣品的質(zhì)量控制及復(fù)方制劑的開發(fā)提供了科學(xué)依據(jù)。

Objective To establish fingerprint chromatogram of the benchmark sample of Linggan Wuwei Jiangxin Decoction and the quantitative determination methods of five key index components, and to study the law of quantity and quality transfer of its benchmark sample. Methods The HPLC fingerprint chromatogram of Linggan Wuwei Jiangxin Decoction was established. The common peaks were attributed through the correlation analysis between the benchmark sample and each single Chinese herbal decoction piece, and identified by reference substances. The quality differences of 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were evaluated by similarity analysis among batches. Meanwhile, the quantitative determination methods of index components such as liquiritin, ammonium glycyrrhetate, 6-gingerol, schizandrin and asarinin were established. The quantity and quality transfer were studied based on the quantitative analysis results and the transfer rates of each index component. Results The HPLC fingerprint chromatograms of 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were established, with a total of 28 common peaks. The similarity among batches was all ≥ 0.950. Through comparison with reference substances, peak 7 was identified as liquiritin, peak 17 as ammonium glycyrrhetate, peak 20 as 6-gingerol, peak 22 as schizandrin, and peak 26 as asarinin. The mass fractions of liquiritin, ammonium glycyrrhetate, 6-gingerol, schizandrin and asarinin in 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were 2.75－4.20, 4.38－7.18, 0.94－1.69, 0.28－0.47, 0.21－0.33 mg·g^-1, respectively. The average transfer rates from Chinese herbal decoction pieces to benchmark samples were 21.57%－35.11%, 16.83%－31.00%, 7.45%－13.64%, 3.13%－5.47%, and 3.15%－5.40%, respectively. Conclusion The established fingerprint chromatogram and multi-index component quantitative determination methods can be used for the quantity and quality transfer analysis of the benchmark sample of the classic prescription Linggan Wuwei Jiangxin Decoction, providing a scientific basis for the quality control of the benchmark sample and the development of compound preparations of this prescription.

R283.6

黑龍江省自然科學(xué)基金資助項(xiàng)目（PL2024H246）；哈爾濱市科學(xué)技術(shù)局科技人才應(yīng)用技術(shù)研究與開發(fā)（青年儲(chǔ)備 A 類）項(xiàng)目（2017RAQXJ127）