星状风毛菊药材分析及质量标准研究

Study on Quality Standard of Saussurea Stella Maxim.

依据《中华人民共和国药典》2020年版的相关要求,对星状风毛菊(Saussurea stella Maxim.)进行系统研究,建立药材质量标准.对药材性状、显微特征进行详细描述,建立薄层色谱鉴别方法.按照药典四部通则对星状风毛菊药材的水分、总灰分、醇溶性浸出物进行测定.采用高效液相色谱法建立星状风毛菊中绿原酸含量测定方法,利用所建方法对不同产地批次的11批样品进行测定.经综合评价,拟定星状风毛菊药材的水分含量不得大于10.0%,总灰分含量不得大于11.0%,醇溶性浸出物含量不得小于16.0%,以干燥品计,绿原酸的含量不低于0.50%.本研究建立的星状风毛菊药材质量标准,具有较好的专属性、准确性和重现性,可为有效控制星状风毛菊药材质量提供科学参考.

According to the relevant requirements of the Pharmacopoeia of the People's Republic of China(2020 edition),the Saussurea stella Maxim.was been systematically studied to establish the quality standard of the herb.The characters and microscopic characteristics of the Saussurea stella Maxim.were described in detail,the thin layer chromatography(TLC)identification method was established.The water contents,total ash and ethanol-soluble extractives were determined accroding to the general four principles of Chinese Pharmacopoeia.The content of chlorogenic acid in Saussurea stella Maxim.was determined by the high performance liquid chromatography(HPLC),and 11 batches of samples from different areas were determined by the developed method.After comprehensive evaluation,the content of water and total ash of the Saussurea stella Maxim.should not exceed 10.0%,11.0%,respectively,while the ethanolsoluble extractive should not be less than 16.0%,and the content of chlorogenic acid should not be less than 0.50% in terms of dried products.The quality standard established in the study has good specificity,accuracy and reproducibility,and can provide a scientific reference for effectively controlling the quality of the Saussurea stella Maxim.