侯建忠，卢建龙，石　健(酒泉市药品检验检测中心中药检测科，甘肃 酒泉　735000)



丹参饮片的质量标准现状及分析

侯建忠*，卢建龙，石健#(酒泉市药品检验检测中心中药检测科，甘肃 酒泉735000)

DOI10.14009/j.issn.1672-2124.2016.02.016

摘要目的：对收集到的市售丹参饮片进行评价性考察，考察丹参饮片的质量。方法：参照《中国药典》2015年版1部的方法，对收集到的70批丹参饮片进行性状、鉴别、检查、丹参酮ⅡA含量测定等项目的检验。结果：本研究中发现72.00%的市售丹参饮片中丹参酮ⅡA的含量达不到丹参药材的国家标准，82.00%的紫丹参中丹参酮ⅡA的含量不符合其质量标准。结论：在药品流通和使用环节，丹参多数是以饮片形式提供给患者使用，及时修订丹参饮片的质量标准是亟待解决的问题。

关键词丹参； 饮片； 质量标准； 含量测定； 丹参酮ⅡA

Quality Standard Status and Analysis of Radix Salvia Miltiorrhiza Decoction Pieces

HOU Jianzhong, LU Jianlong, SHI Jian(Testing Department of Trational Chinese Medicine, Jiuquan Center for Drug Inspection and Testing, Gansu Jiuquan 735000, China)

ABSTRACTOBJECTIVE：To investigate and evaluate the quality of radix salviae miltiorrhizae decoction pieces in current market. METHODS: According to Chinese Pharmacopoeia(2015 Version, 1 Chapter), 70 batches of radix salviae miltiorrhizae decoction pieces were determined in terms of characteristics, identification, examination and tanshinone ⅡAcontents, etc. RESULTS: The contents of tanshinone ⅡAcould not meet the national standards of radix salviae miltiorrhizae among 72.00% of decoction pieces in current market. And the contents of tanshinone ⅡAwere out of quality specifications among 82.00% of purple radix salviae miltiorrhizae. CONCLUSIONS: In the process of drug circulation and use, radix salviae miltiorrhizae are mostly used in the form of decoction pieces for patients. Therefore, it is necessary to revise the quality specifications of radix salviae miltiorrhizae decoction pieces without delay.

KEYWORDSRadix salviae miltiorrhizae; Decoction pieces; Quality standard; Content determination; Tanshinone ⅡA

丹参为唇形科植物Salvia miltiorrhiza Bunge．的根及根茎，具有祛瘀止痛、活血通经、清心除烦的功效，用于治疗心绞痛、冠心病等，一直为临床常用中药。目前，丹参的商品药材主要分为野生丹参和家种丹参两类。文献报道，丹参药材的来源涉及植物有丹参、甘西鼠尾、滇丹参、南丹参、三叶丹参及其变种或变型等十余种(含变种、变型)。同时丹参也存在小叶型、大叶型、单叶型、皱叶型和白花丹参等一些种内变异。由于丹参品种较多，本研究试图找到适合的方法、指标物质，以对其饮片质量进行控制。通过收集到的70批丹参饮片，采用丹参酮ⅡA作为指标物质[1]，参照《中国药典》2010年版1部[2]的含量测定方法，进行了质量考察研究，现报告如下。……