Recommendations on quality standards of Alismatis Rhizoma in Chinese Pharmacopoeia(2020 edition)

ZHAO Xiao-mei1,2 TIAN Shuang-shuang1 LIU Shan-shan1 QU Qian1 ZHAO Jing-yuan1 YAN Li-hua1 WANG Zhi-min1

(1.National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China 100700)
(2.Shanxi University of Chinese Medicine, Jinzhong, China 030619)

【Abstract】The present research was launched to improve the quality standards of Alismatis Rhizoma and supply scientific evidence and recommendations for the quality control of Alismatis Rhizoma in Chinese Pharmacopoeia(Ch. P) 2020 edition. The contents of water, total ash, heavy metals and deleterious element, pesticide residues and alcohol-soluble extract were analyzed according to the methods listed in the volume Ⅳ of Ch. P 2015 edition. Alisol B 23-acetate, alisol C 23-acetate and reference herbs were used to identify Alismatis Rhizoma by TLC method, which was developed by using a mixture of dichloromethane-methanol(15∶1) as developing solvent on silica gel GF254 precoated plates. In HPLC method, alisol B 23-acetate and alisol C 23-acetate were separated with acetonitrile-water as the mobile phase and detected at 208 nm and 246 nm, respectively. Thirty-seven batches of crude drugs, thirty batches of prepared slices and nineteen batches of salt prepared slices of Alismatis Rhizoma were determined according to the methods established. The quality standards established based on the research results were specific and repeatable, and suitable for the quality evaluation of Alismatis Rhizoma. We recommended that the botanical sources, TLC examination, alcohol-soluble extract of salt prepared slices and content determination should be revised in the Ch. P 2020 edition.

【Keywords】 Alismatis Rhizoma; quality standards; alisol B 23-acetate; alisol C 23-acetate; TLC; HPLC;


【Funds】 Research Project of Standard Formulation and Revision of the Chinese Pharmacopoeia Commission (Grant No. 2018Z079) National Standardization Project of Traditional Chinese Medicine (Grant No. ZYBZH-C-JL-24)

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This Article


CN: 11-2272/R

Vol 45, No. 07, Pages 1566-1577

April 2020


Article Outline


  • 1 Materials
  • 2 Methods and results
  • 3 Discussion
  • References