中文摘要：

中药标准物质替代测定法是符合中药特点的多指标质量控制的一种有效模式。为了指导该法的建立,统一并规范该法的研究及在国家药品标准中的应用,并证明采用的方法是否适合于相应的检测要求,探讨并提出本技术指导原则。本指导原则从该法的定义与分类、定量的原理与方法、色谱峰的定位与确认、技术要求四个方面进行论述。当中药指纹图谱（特征图谱）鉴别项或多指标含量测定项采用中药标准物质替代测定法时,按照本原则进行方法学验证研究。

英文摘要：

Substitute reference substance method is an effective approach for quality control of multiple components in accordance with the characteristics of traditional Chinese medicines.The purpose of the guideline is to guide the establishment of substitute reference substance method,prove the conformance of the method to the requirements for testing,and standardize the study method and its application in national drug standards.The topics of the guideline include the definition and classification of substitute reference substance method,the principles and approaches of quantitative analysis,the identification and confirmation of chromatographic peaks,and technical requirements.When substitute reference substance method is used for fingerprint identification or multiple components assay in traditional Chinese medicines,the analytical method can be validated following the guideline.