Indrayanto Gunawan
Plant Biotechnology Research Group, Faculty of Pharmacy, Airlangga University, Surabaya, Indonesia.
Profiles Drug Subst Excip Relat Methodol. 2018;43:359-392. doi: 10.1016/bs.podrm.2018.01.003. Epub 2018 Mar 6.
It is well known that the quality control (QC) of drugs derived from herbs (DDHs) has two main problems: first, DDHs are chemically complex mixtures, and second, the chemical contents of raw plant materials are affected by the site of cultivation, age of plants, methods of harvesting, and processing. QC is used by manufacturers to ensure the consistency, safety, and efficacy of the DDHs. QC of DDHs can be performed by two approaches, namely, marker-oriented and chemical pattern-oriented (metabolite profiling) using chromatographic methods. For having reliable results of any chemical analysis that will be performed in the QC laboratory, the method of analysis must be validated first before it can be routinely applied. Parameters of the validation method that should be evaluated for marker-oriented approach are stability, selectivity, linearity, trueness, precision, and robustness/ruggedness, while for metabolite profiling approach stability, intra- and interday precisions should be determined. Determination of instrumental and sample detection limit (DL), quantification limit (QL), and cutoff value is described in this review. Some relatively new validation methods that could correlate trueness and precision will be also discussed. The importance and application of metabolite profiling for a QC laboratory at pharmaceutical industry are discussed.
众所周知，草药衍生药物（DDHs）的质量控制（QC）存在两个主要问题：第一，DDHs是化学复杂混合物；第二，原料植物的化学成分受种植地点、植物年龄、收获方法和加工方式影响。制造商使用QC来确保DDHs的一致性、安全性和有效性。DDHs的QC可通过两种方法进行，即使用色谱方法的基于标志物的方法和基于化学模式的方法（代谢物谱分析）。为了在QC实验室进行的任何化学分析获得可靠结果，分析方法必须先经过验证，才能常规应用。对于基于标志物的方法，应评估的验证方法参数包括稳定性、选择性、线性、准确性、精密度以及稳健性/耐用性，而对于代谢物谱分析方法，则应确定稳定性、日内和日间精密度。本文综述了仪器和样品检测限（DL）、定量限（QL）和截断值的测定方法。还将讨论一些能够关联准确性和精密度的相对较新的验证方法。本文讨论了代谢物谱分析在制药行业QC实验室中的重要性和应用。
