Li Zhi, Merfort Irmgard, Reich Eike
Albert-Ludwigs-University, Department of Pharmaceutical Biology and Biotechnology, Freiburg, Stefan-Meierstr. 19, 79104 Freiburg, Germany.
J AOAC Int. 2010 Sep-Oct;93(5):1390-8.
Due to their complexity, multicomponent herbal drugs pose enormous analytical challenges for quality control (QC). Although they may have traditionally been used for hundreds of years, the information about their chemical composition is often still limited. Selecting suitable markers to monitor the identity and potency of the mixture is, therefore, difficult. There is also the possibility of natural variability for each plant. This paper illustrates a pragmatic and practical approach to QC of a multicomponent herbal drug by HPTLC. Cangzhu xianglian xan (CXS), composed of the herbal drugs Coptis rhizome, Aucklandia root, and Atractylodes rhizome (30 + 20 + 60, w/w/w), is used as an example. A characteristic fingerprint can be generated for CXS with toluene-ethyl acetate-methanol-isopropanol-water (60 + 30 + 20 + 15 + 3, v/v/v/v/v) mobile phase on HPTLC silica gel 60 conditioned with ammonia. While the corresponding monograph of the Chinese Veterinary Pharmacopoeia focuses only on the detection of berberine, one of the principal components of Coptis rhizome, the proposed method of identification determines the presence of all three components in the drug after derivatization with anisaldehyde reagent. The same method can also be used to quantitatively determine the content of berberine by scanning densitometry. This paper provides details about the validation of the qualitative and quantitative determinations.
由于其复杂性,多成分草药制剂给质量控制(QC)带来了巨大的分析挑战。尽管它们可能已经被传统使用了数百年,但关于其化学成分的信息往往仍然有限。因此,选择合适的标志物来监测混合物的身份和效力是困难的。每株植物也存在自然变异性的可能性。本文阐述了一种通过高效薄层色谱法(HPTLC)对多成分草药制剂进行质量控制的实用方法。以苍术香连散(CXS)为例,其由黄连根茎、木香根和白术根茎(30 + 20 + 60,w/w/w)组成。在经氨处理的HPTLC硅胶60上,以甲苯 - 乙酸乙酯 - 甲醇 - 异丙醇 - 水(60 + 30 + 20 + 15 + 3,v/v/v/v/v)为流动相,可以生成CXS的特征指纹图谱。虽然《中国兽药典》的相应专论仅侧重于检测黄连根茎的主要成分之一小檗碱,但所提出的鉴别方法在用茴香醛试剂衍生化后可确定药物中所有三种成分的存在。同样的方法也可用于通过扫描密度法定量测定小檗碱的含量。本文提供了定性和定量测定验证的详细信息。