Liang Yao-Hua, Li Chun, Feng Wei-Hong, Liu Xiao-Qian, Chen Liang-Mian, Zhu Jing-Jing, Yan Li-Hua, Meng Chen-Xiao-Ning, Guo Zhong-Yuan, Gao Hui-Ming, Wang Zhi-Min
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines Beijing 100700, China.
Key Laboratory of SATCM for Process Analysis Technology of Chinese Herbal Medicines Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(2):391-397. doi: 10.19540/j.cnki.cjcmm.20200706.203.
This paper aims to solve the problems of complicated-unstable test solution preparation process and insufficient extraction of the active ingredient astragaloside Ⅳ in the legal method for the determination of astragaloside Ⅳ in Astragali Radix. The continuous single-factor analysis of seven main factors affecting the content of astragaloside Ⅳ was carried out by HPLC-ELSD, and then the pre-paration method of test solution was optimized. This optimized method exhibited excellent performance in precision, repeatability and stability. The average recovery rate of astragaloside Ⅳ was 99.65% with RSD 2.2%. Astragaloside Ⅳ showed a good linearity between the logarithm of peak area and the logarithm of injection quantity in the range of 0.46-9.1 μg(r=0.999 6). The contents of astragaloside Ⅳ in 29 batches of Astragali Radix were determined by the new and the legal methods. The results showed that the average content of astragaloside Ⅳ in these Astragali Radix samples determined by the former method was 1.458 times than that of the latter one, indicating the new method was simple, reliable and more adequate to extract target compound. According to the results, it is suggested to improve the content standard of astragaloside Ⅳ in Astragali Radix in the new edition of Chinese Pharmacopeia.
本文旨在解决《中国药典》中黄芪甲苷含量测定法定方法存在的供试品溶液制备过程复杂不稳定、有效成分黄芪甲苷提取不充分的问题。采用高效液相色谱 - 蒸发光散射检测器（HPLC - ELSD）对影响黄芪甲苷含量的七个主要因素进行连续单因素分析，进而优化供试品溶液的制备方法。该优化方法在精密度、重复性和稳定性方面表现优异。黄芪甲苷的平均回收率为99.65%，相对标准偏差（RSD）为2.2%。黄芪甲苷在0.46 - 9.1μg范围内，峰面积对数与进样量对数之间呈良好的线性关系（r = 0.999 6）。采用新方法和法定方法测定了29批黄芪中黄芪甲苷的含量。结果表明，用前一种方法测定的这些黄芪样品中黄芪甲苷的平均含量是后一种方法的1.458倍，表明新方法简便、可靠，更适合提取目标化合物。根据结果，建议在新版《中国药典》中提高黄芪中黄芪甲苷的含量标准。
