药检分析实验室面临草药的挑战

Herbal Medicines-Analytical Challenges Faced by Regulatory Laboratory

介绍澳大利亚医疗用品管理局 (TGA)对草药的管理以及政府化验室在草药分析中面临的挑战及对策。重点介绍了该化验所利用色谱指纹图谱在检验草药制剂的应用情况和经验。并举例说明建立色谱指纹图谱的基本原则和方法学问题。

In the lecture, the regualtion on complementary medicine in TGA Australia has been briefly introduced. The minor active or harmful constituents and too many unknown components comtained in herbal medicine need to be detected is the analytical challenge faced by regulatory laboratory in Australia. The examples demonstrated what efforts the laboratory has made painstaking to establish chromatographic fingerprinting to meet the aim for quality control of herbal medicine which marketed in Australia. The principle and key factors for chromatographic fingerprint technique has been described.