Improving Quality Standard of Processed Slices of Paridis Rhizoma of Chinese Pharmacopoeia

Bo-ya JU; Yan-min LI; Hou-da ZHU; Yun-ge FANG; Rui WANG; Liang-mian CHEN; Hui-min GAO; Zhi-min WANG

doi:10.13422/j.cnki.syfjx.20191617

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Improving Quality Standard of Processed Slices of Paridis Rhizoma of Chinese Pharmacopoeia

Resource and Quality Evaluation | 更新时间：2021-02-09

- Improving Quality Standard of Processed Slices of Paridis Rhizoma of Chinese Pharmacopoeia
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 25, Issue 19, Pages: 93-101(2019)
- 作者机构：
  
  1.山西中医药大学，太原　 030619；
  2.中国中医科学院　中药研究所，中药质量控制技术国家工程实验室，北京　 100700；
  3.河南中医药大学　药学院，郑州　 450008
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20191617
  CLC： R284.2; R289; R22; R2-031
- Received：08 March 2019，
  
  Published Online：08 May 2019，
  
  Published：05 October 2019
- 稿件说明：
移动端阅览
Bo-ya JU, Yan-min LI, Hou-da ZHU, et al. Improving Quality Standard of Processed Slices of Paridis Rhizoma of Chinese Pharmacopoeia[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 93-101.
DOI：

Bo-ya JU, Yan-min LI, Hou-da ZHU, et al. Improving Quality Standard of Processed Slices of Paridis Rhizoma of Chinese Pharmacopoeia[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 93-101. DOI： 10.13422/j.cnki.syfjx.20191617.

摘要

目的：

开展重楼饮片【性状】【薄层鉴别】和【含量测定】研究，为完善2020年版《中国药典》重楼饮片质量标准提供参考。

方法：

采用文献总结和实际样品观察进行性状描述；采用薄层色谱法进行定性鉴别；采用高效液相色谱法测定市售和自制饮片中重楼皂苷Ⅰ，Ⅱ，Ⅵ和Ⅶ的含量；采用UPLC法测定自制饮片中10种甾体皂苷(伪原薯蓣皂苷，重楼皂苷Ⅶ，17-羟基纤细薯蓣皂苷，重楼皂苷H，重楼皂苷Ⅵ，重楼皂苷Ⅱ，薯蓣皂苷，纤细薯蓣皂苷，重楼皂苷Ⅰ和重楼皂苷Ⅴ)的含量。

结果：

饮片外观性状上，除了色泽、质地、气味，增加直径1.0～4.5 cm的限定。薄层色谱图中正品重楼多不能检出重楼皂苷Ⅵ，伪品头顶一颗珠在相应位置斑点清晰。13批市售样品中只有5批符合现行2015年版《中国药典》规定的“重楼皂苷Ⅰ，Ⅱ，Ⅵ和Ⅶ之和不低于0.6%的要求”。炮制过程软化和干燥方式对甾体皂苷含量有明显影响，以浸泡、晒干较好。

结论：

建议新增性状，将重楼皂苷Ⅵ从薄层鉴别删除，以重楼皂苷H替代重楼皂苷Ⅵ进行含量限度控制，规定“重楼皂苷Ⅰ，Ⅱ，H和Ⅶ之和应不低于1.0%”。

Abstract

Objective:

To study the appearance description

TLC examination and content determination was carried out

in order to improve the quality standard of processed slices of Paridis Rhizoma in the 2020 edition of

Chinese Pharmacopoeia

Method:

Based on the literature review and observation on the samples

the appearance description was described. TLC examination was used for the qualitative analysis. HPLC was used for the determination of polyphyllin Ⅰ

Ⅱ

Ⅵ and Ⅶ in the commercial and processed samples. UPLC was employed for the determination of 10 steroidal saponins

namely pseudoprotodioscin

polyphyllin Ⅶ

17-hydroxygracillin

polyphyllin H

polyphyllin Ⅵ

polyphyllin Ⅱ

dioscin

gracilin

polyphyllin Ⅰ and polyphyllin Ⅴ.

Result:

For the appearance description

color and luster

texture

odor and taste as well as the diameter of 1.0-4.5 cm were recorded. polyphyllin Ⅵ was not detected in the thin layer chromatograms of most of the tested samples derived from high-quality species but obviously detected in those of Trillium Rhizoma. Five of 13 commercial samples met the requirements that the total amounts of polyphyllin Ⅶ

Ⅵ

Ⅱ

and Ⅰ should be no less than 0.6%according to the current

Chinese Pharmacopoeia

. Because softening and drying had the obvious influence on the contents of steroidal saponins in the samples

soaking and sun-drying were preferred.

Conclusion:

Appearance description should be supplemented. Polyphyllin Ⅵ is not considered as one of quality markers for the TLC identification and HPLC determination of Paridis Rhizoma. Polyphyllin H was considered as a new marker for the quality control. It is recommended that the total amounts of polyphyllin Ⅶ

Ⅱ

and Ⅰ should be no less than 1.0%.

关键词

Keywords

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