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丹参产品质量控制方法的改进——兼顾亲水性和脂溶性活性成分

Improved quality control method for Danshen products--consideration of both hydrophilic and lipophilic active components.

作者信息

Zhou Limin, Chow Moses, Zuo Zhong

机构信息

School of Pharmacy, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, PR China.

出版信息

J Pharm Biomed Anal. 2006 Jun 7;41(3):744-50. doi: 10.1016/j.jpba.2005.12.032. Epub 2006 Feb 2.

DOI:10.1016/j.jpba.2005.12.032
PMID:16458472
Abstract

The current study intends to provide an improved quality control analysis for Danshen product-a representative herbal product with known active components that are both hydrophilic and lipophilic in nature. A simple HPLC method with photodiode-array (PDA) ultraviolet detection was developed for the simultaneous determination of three major lipophilic components (cryptotanshinone, tanshinone I and tanshinone IIA) and three major hydrophilic components (danshensu, protocatechuic aldehyde and salvianolic acid B) of Danshen (Salvia miltiorrhiza). These six components were successfully separated using Radial-pak C18 cartridge with the elution gradient consisting of 0.5% acetic acid in water and 0.5% acetic acid in acetonitrile at a flow rate of 1 ml/min. The intra-day and inter-day precisions of the analysis were within 2.32 and 2.0%, respectively. The detection limits were 0.02, 0.01, 0.01, 0.05, 0.005 and 0.02 microg/ml for cryptotanshinone, tanshinone I, tanshinone IIA, danshensu, protocatechuic aldehyde and salvianolic acid B, respectively. The developed method has been applied to the simultaneous determination of above six major components in Fufang Danshen Tablet and Dripping Pill products by extraction with methanol and water. It has been demonstrated that salvianolic acid B and danshensu are the major components among the eight commercial Fufang Danshen products studied. The current developed method with methanol as extraction solvent provides a simple and efficient method for simultaneous detection of both lipophilic and hydrophilic major components in Danshen products.

摘要

本研究旨在为丹参产品提供改进的质量控制分析,丹参产品是一种具有代表性的草药产品,其已知活性成分兼具亲水性和脂溶性。开发了一种采用光电二极管阵列(PDA)紫外检测的简单高效液相色谱法,用于同时测定丹参(Salvia miltiorrhiza)中的三种主要脂溶性成分(隐丹参酮、丹参酮I和丹参酮IIA)以及三种主要亲水性成分(丹参素、原儿茶醛和丹酚酸B)。使用径向Pak C18柱成功分离了这六种成分,洗脱梯度由0.5%乙酸水溶液和0.5%乙酸乙腈溶液组成,流速为1 ml/min。该分析方法的日内和日间精密度分别在2.32%和2.0%以内。隐丹参酮、丹参酮I、丹参酮IIA、丹参素、原儿茶醛和丹酚酸B的检测限分别为0.02、0.01、0.01、0.05、0.005和0.02 μg/ml。所建立的方法已应用于通过甲醇和水提取同时测定复方丹参片和滴丸产品中的上述六种主要成分。结果表明,在所研究的八种市售复方丹参产品中,丹酚酸B和丹参素是主要成分。目前以甲醇为提取溶剂开发的方法为同时检测丹参产品中的亲水性和脂溶性主要成分提供了一种简单有效的方法。

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