基于HPLC-DAD-MS_MS的不同来源生脉产品质量评价.docVIP

 基于 HPLC-DAD-MS/MS 的不同来源生脉 产品质量评价# 王艳慧，朱丹妮** 5 10 15 20 25 30 （中国药科大学中药复方研究室） 摘要：目的：建立 HPLC-DAD-ESI/MS/MS 分析方法对不同厂家的生脉产品进行评价。方法： 采用 HPLC-DAD-ESI/MS/MS 分析方法对主要成分峰进行结构鉴定。结果：基于色谱保留时 间、紫外吸收光谱、分子量和多级质谱等信息，鉴定分析了 12 批生脉散提取物中的 45 个共 有峰。在已建立的 HPLC-DAD-MS/MS 分析方法基础上，进一步对生脉散 2 种剂型、9 个品 牌的商业化产品进行了质量评价。结论：不同厂家在产品制备环节由于采用的药材质量参差 不齐，制备工艺存在差别，造成成品制剂的质量存在明显的差异。在产品制备过程中应注意 控制药材质量、提高工艺流程和质量控制水平，以确保产品的药效。 关键词：中药分析；生脉散；HPLC-DAD-MS/MS；成分鉴定 中图分类号：R284. 1 Identi?cation of multiple constituents in the commercial products of Sheng-Mai San by HPLC–DAD–MS/MS WANG Yanhui, ZHU Danni* (Department of Complex Prescription of TCM, China Pharmaceutical University) Abstract: A high-performance liquid chromatography-diode array detection–tandem mass spectrometry (HPLC-DAD-MS/MS) method has been firstly developed for chemical fingerprint analysis of SMS extract and rapid identification of major compounds in the fingerprints. Comparing the UV and MS spectra with those of reference compounds, 45 peaks in the fingerprints were identified. Moreover, similarity analysis, were employed to evaluate 12 samples of SMS extract. Based on the established LC-MS method, nine brands of SMS products including two different dosage forms were evaluated. The results showed that not only the strictly quality regulation during the preparation procedure is important, but also the quality control of Chinese medical materials is indispensable. The application of the method to the commercial products of SMS provided the chemical support for the chromatographic fingerprint technology and facilitates to improve the quality control standard of this age-old TCM formula. Key words: Analysis of traditional traditional Chinese Medicine; Sheng-Mai San; HPLC-DAD-MS/MS; Constituents identification 35 40  引言 生脉散是已有 810 多年历史的著名古方[1]，最早见于金代张元素的《医学启 源》，由人参 Panax ginseng C.A Mey.、麦冬 Ophiopogon japonicus (Thunb.) KerGawl、五味子 Schisandra chinensis (Turcz.) Baill.三味中药组成。具有“益气养 阴、保肺生脉”的功能。古代医家既用此药剂以抢救热伤元气、津液耗伤、脉微 欲绝等重症，又用它作为气阴两虚病人的补益剂