HPLC法测定药典方丹参片中丹参酮ⅡA及丹酚酸B含量.doc

HPLC法测定药典方丹参片中丹参酮ⅡA及丹酚酸B含量[摘要] 目的：完善药典方丹参片的质量标准，测定制剂中丹参酮ⅡA及丹酚酸B的含量，考察制备工艺中有效成分的转移率。方法：采用HPLC法进行含量测定。丹参酮ⅡA，以甲醇-水（80∶20）为流动相，检测波长为270 nm；丹酚酸B以甲醇-乙腈-甲酸-水(30∶10∶1∶59)，检测波长为286 nm。结果：3批丹参片平均含丹参酮ⅡA 2.83 mg/g，转移率为42.3%；丹酚酸B含量为 51.8 mg/g，转移率为50.9%。结论：建立了丹参片中丹参酮ⅡA的含量测定方法，可以更好地控制丹参片的质量。 [关键词] 丹参片；丹参酮ⅡA；丹酚酸B；HPLC [中图分类号]R917 [文献标识码]A [文章编号]1673-7210（2008）08（b）-030-03 Quantitative determination of tanshinoneⅡA and salvianolic acid B in pharmacopoeial prescription Danshen Tablets by HPLC LIU Tao (Center for Certification and Evaluation, Shanghai Food and Drug Administration, Shanghai 200020, China) [Abstract] Objective: To determine tanshinoneⅡA and salvianolic acid B in Danshen Tablets quantitatively. Methods: HPLC with Hypersil ODS column was used in the content determination. For tanshinoneⅡA , the mobile phase was composed of methanol-water (80∶20) and the detective wavelength was at 270 nm. For salvianolic acid B, the mobile phase was composed of methanol-acetonitrile-formic acid-water (30∶10∶1∶59) and the detective wavelength was at 286 nm. Results: The average contents of tanshinoneⅡA and salvianolic acid B in three batch of tablets were 2.83 mg/g and 51.8 mg/g respectively. The extraction rate of the preparation processes were 42.3% and 50.9% respectively. Conclusion: The method is available with a good reproducibility and can control the quality of Danshen Tablets effectively. [Key words] Danshen Tablets；TanshinoneⅡA；Salvianolic acid B；HPLC 丹参片为《中国药典》2005版一部收载的成方制剂，是单味丹参提取制得的片剂，功能活血化瘀，主要用于冠心病心绞痛等疾病[1]。丹参为唇形科植物丹参Salvia miltiorrhiza Bge. 的干燥根及根茎，同时含有脂溶性和水溶性两大类活性成分。丹参脂溶性成分大多为共轭醌、酮类化合物，具有特征的橙黄色和橙红色，代表性成分有丹酮ⅡA、丹参酮ⅡB、隐丹参酮等；水溶性成分主要为酚酸类物质，代表性成分有丹参素、原儿茶醛、原儿茶酸、丹酚酸A、丹酚酸B等[2]。 《中国药典》2005版一部中，丹药材项下已规定同时测定丹参酮ⅡA及丹酚酸B的含量来控制丹参药材的质量，但丹参片中并未收载丹参酮ⅡA的含量测定方法[1]。为更好地控制丹参片的质量，本文建立测定丹参片中丹参酮ⅡA及丹酚酸B的含量，并探讨制备工艺对两种成分转移率的影响。 1 仪器与试药 高效液相色谱仪（Aglient 1100，Aglient Technologies），HYPERSIL C18柱（4.6 mm×250 mm，5 μm）（大连依利特科学仪器有限公司）。 丹参酮ⅡA对照品（110766-200315）、丹酚酸B对照品（111562-2