Abstract：
The quality standards for Andrographis paniculata, a widely used medicinal herb, exhibited significant variations across different pharmacopeias. In this study, we compared the HPLC content determination methods and total lactone content of A. paniculata samples from different regions, as specified in the Chinese (CP), United States (USP), European (EP), Thai (TP), and Indian pharmacopeias (IP), as well as the Hong Kong Chinese Materia Medica Standards (HK). We aimed to assess the differences and similarities among these pharmacopeias and harmonized international quality standards for A. paniculata. The analysis revealed variations in sample preparation, liquid chromatographic conditions, fingerprint profiles, and total lactone content among the different pharmacopeias. Specifically, the CP and HK methods exhibited superior sample preparation and chromatographic separation. Further comparing the content of 20 A. paniculata samples with the CP, USP, EP and HK methods showed consistent determinations for the same components, indicating similar detection capabilities. The discrepancies in total lactone content primarily stemmed from differences in the number and types of detected compounds. Moreover, the acceptance criteria exhibited a stringency in the order CP > HK > EP > USP. In conclusion, this comparison analysis of content determination in CP, USP, HK, EP, TP and IP provided a scientific foundation for the international standardization and trade regulations of A. paniculata. It also served as a valuable reference for the development of international quality standards for other medicinal herbs, facilitating the harmonization of global pharmaceutical standards.
摘要：
穿心莲的质量标准,一种广泛使用的草药，在不同药典中表现出显著差异。在这项研究中,我们比较了不同地区的A.paniculata样品的HPLC含量测定方法和总内酯含量，如中文(CP)所述，美国(USP),欧洲(EP),泰语(TP),和印度药典(IP)，以及香港中药标准（香港）。我们旨在评估这些药典之间的差异和相似性，以及A.paniculata的统一国际质量标准。分析显示样品制备的差异，液相色谱条件，指纹配置文件，和不同药典之间的总内酯含量。具体来说,CP和HK方法表现出优异的样品制备和色谱分离。进一步比较20A的含量与CP，USP,EP和HK方法对相同成分的测定结果一致，表明类似的检测能力。总内酯含量的差异主要源于检测到的化合物的数量和类型的差异。此外，验收标准表现出严格性，顺序为CP>HK>EP>USP。总之,CP中含量测定的比较分析，USP,香港，EP,TP和IP为A.paniculata的国际标准化和贸易法规提供了科学依据。也为其他药材制定国际质量标准提供了有价值的参考,促进全球制药标准的协调。
