Ju Bo-Ya, Zhu Hou-da, Li Yan-Min, Wang Rui, Chen Liang-Mian, Gao Hui-Min, Wang Zhi-Min
National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China School of Pharmacy, Henan University of Chinese Medicine Zhengzhou 450008, China.
Zhongguo Zhong Yao Za Zhi. 2020 Apr;45(8):1745-1755. doi: 10.19540/j.cnki.cjcmm.20200330.201.
Paridis Rhizoma is prepared from the dried rhizoma of Paris polyphylla var. yunnanensis or P. polyphylla var. chinensis. For the improvement of the quality standard of Paridis Rhizoma described in Chinese Pharmacopoeia(2015 edition), it is proposed that the quality marker no longer contains polyphyllin Ⅵ, and instead, polyphyllin H is an alternative for the quantitative analysis. To determine polyphyllin Ⅰ, Ⅱ, H and Ⅶ in the Paridis Rhizoma samples collected from the different growing area in China, HPLC method was established using the same chromatographic conditions as those for simultaneous determination of polyphyllin Ⅰ, Ⅱ, Ⅵ and Ⅶ described in Chinese Pharmacopoeia(2015 edition). The methodology validation indicated that there was a good linearity among the ranges of 0.006 48-0.828, 0.006 52-0.834, 0.006 17-0.790, 0.006 31-0.808 g·L~(-1) for polyphyllin Ⅰ, Ⅱ, H and Ⅶ, respectively. The average recoveries of four components were 100.2%-101.4%, with RSD less than 3.5%. The total amount of polyphyllin Ⅰ, Ⅱ, H and Ⅶ in the analyzed samples of P. polyphylla var. chinensis and P. polyphylla var. yunnanensis ranged from 0.050 9% to 3.99% and from 0.115% to 3.23%, respectively. In the tested samples collected from other Paris plants, there are high content of steroidal saponins in the samples of P. fargesii and P. forrestii, low content in the samples of P. polyphylla var. stenophylla, P. delavayi and P. thibetica, and almost not occurrence in the sample of P. mairei. As a representative adulterant of Paridis Rhizoma processed slices, 7 batches of Trillium samples contained high amount of polyphyllin Ⅵ and did not have polyphyllin H. Based on the present investigation, it is recommended that polyphyllin H together with polyphyllin Ⅰ, Ⅱ and Ⅶ are suitable for the improvement of quality standard of Paridis Rhizoma and the total amount of four components are not less than 0.80%.
重楼是由云南重楼或七叶一枝花的干燥根茎炮制而成。为提高《中国药典》（2015年版）中重楼质量标准，建议质量控制指标不再包含重楼皂苷Ⅵ，而用重楼皂苷H作为定量分析的替代指标。为测定采自中国不同产地的重楼样品中重楼皂苷Ⅰ、Ⅱ、H和Ⅶ的含量，采用与《中国药典》（2015年版）中同时测定重楼皂苷Ⅰ、Ⅱ、Ⅵ和Ⅶ相同的色谱条件建立了HPLC法。方法学验证表明，重楼皂苷Ⅰ、Ⅱ、H和Ⅶ分别在0.006 48 - 0.828、0.006 52 - 0.834、0.006 17 - 0.790、0.006 31 - 0.808 g·L⁻¹范围内线性关系良好。4种成分的平均回收率为100.2% - 101.4%，RSD小于3.5%。华重楼和云南重楼供试样品中重楼皂苷Ⅰ、Ⅱ、H和Ⅶ的总量分别为0.050 9%至3.99%和0.115%至3.23%。在所检测的其他重楼属植物样品中，球药隔重楼和大理重楼样品中甾体皂苷含量较高，狭叶重楼、大花重楼和西藏重楼样品中含量较低，而黑籽重楼样品中几乎未检出。作为重楼饮片的代表性伪品，7批延龄草样品中重楼皂苷Ⅵ含量较高且不含重楼皂苷H。基于本研究，建议将重楼皂苷H与重楼皂苷Ⅰ、Ⅱ和Ⅶ一起用于提高重楼的质量标准，4种成分总量不得低于0.80%。
