(2.山西中医药大学, 山西晋中 030619)
【摘要】完善泽泻药材和饮片的质量标准,为《中国药典》2020年版泽泻药材和饮片质量标准的修订提供参考和建议。参照《中国药典》2015年版四部通则,对泽泻药材和饮片的水分、总灰分、重金属及有害元素、农药残留及醇溶性浸出物进行测定;以硅胶GF254板为薄层板,以二氯甲烷-甲醇(15∶1)为展开剂,建立了以23-乙酰泽泻醇B和23-乙酰泽泻醇C及泽泻对照药材为对照的薄层鉴别方法;采用HPLC,以乙腈-水为流动相,梯度洗脱,在208 nm和246 nm波长下分别对23-乙酰泽泻醇B和23-乙酰泽泻醇C进行定量分析。采用建立的方法,对37批泽泻药材、30批泽泻饮片和19批盐泽泻的质量进行评价,根据实验结果,建立了泽泻药材和饮片的质量标准。该标准具有很好的专属性和重复性,可用于泽泻药材与饮片的质量控制。建议《中国药典》2020年版对泽泻的【来源】、【鉴别】(薄层)、【浸出物】(盐泽泻)、【含量测定】项进行相应的修订。
【基金资助】 国家药典委员会标准制修订研究课题(2018Z079); 国家中药标准化项目(ZYBZH-C-JL-24);
Recommendations on quality standards of Alismatis Rhizoma in Chinese Pharmacopoeia(2020 edition)
(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);
 ZHAO X P, LU L, ZHANG Y F, et al. Study on discriminating nephrotoxic components in zexie [J]. China Journal of Chinese Materia Medica, 2011, 36 (6): 758–761 (in Chinese).
 Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia. Vol. One [S]. Beijing: China Medical Science Press, 2015: 229 (in Chinese).
 CHEN R S. 药物出产辨(八) [J]. Pharmacy and Clinics of Chinese Materia Medica, 2011, 2 (4): 22 (in Chinese).
 National Administration of Traditional Chinese Medicine. 中华本草. Vol. Eight [M]. Shanghai: Shanghai Scientific & Technical Publishers, 1999: 3 (in Chinese).
 ZHANG X, LI X Y, LIN N, et al. Diuretic activity of compatible triterpene components of Alismatis Rhizoma [J]. Molecules, 2017, 22 (9): 1459.
 XU F, YU H, LU C, et al. The cholesterol-lowering effect of alisol acetates based on HMG-CoA reductase and its molecular mechanism [J]. Evid Based Complement Alternat Med, 2016, doi: 10.1155/2016/4753852.
 LI X Y, LI X J, LIU C K, et al. Effects of Triterpenes Isolated from Rhizoma Alismatis on Glucose Uptake in 3T3-L1 Cells [J]. Journal of Fujian University of Traditional Chinese Medicine, 2014, 24 (5): 31 (in Chinese).
 Jin Q H, Hou J J, Zhang J Q, et al. Research Progress on Effective Material Basis of Rhizoma Alismatis and Reflection on Existing Quality Problems [J]. Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology, 2019, 21 (5): 821 (in Chinese).
 ZHANG Y M, SUN F L, LU X H, et al. Correlation study between accumulation of triterpenoids and expression of relative genes in Alisma orientale [J]. China Journal of Chinese Materia Medica, 2019, 44 (5): 942 (in Chinese).
 TAI Y N, WU X, FAN L M, et al. Simultaneous determination of sixteen components in Alismatis Rhizoma by UPLC-MS/MS [J]. Chinese Journal of Pharmaceutical Analysis, 2018, 38 (8): 1337 (in Chinese).
 TAI Y N, WENG Y H, ZHANG S P, et al. Determination of seven ingredients of different grades Alismatis Rhizoma by QAMS method [J]. China Journal of Chinese Materia Medica, 2019, 44 (11): 2292 (in Chinese).
 GU L Q, HUANG L L, XIE P D, et al. The Research Status of Chinese Medicinal Herbs Zexie (Rhizoma Alismatis) and Its Enlightenment to Guangxi [J]. Guiding Journal of Traditional Chinese Medicine and Pharmacy, 2019, 25 (6): 60 (in Chinese).
 ZHANG H J, GONG S X, XU J, et al. Research progress of Alismatis Rhizoma and prediction analysis on its Q-marker [J]. Chinese Traditional and Herbal Drugs, 2019, 50 (19): 4741 (in Chinese).
 LIU S S, SHENG W L, LI Y, et al, Chemical constituents from Alismatis Rhizoma and their anti-inflammatory activities in vitro and in vivo [J]. Bioorg Chem, 2019, doi: 10.1016/j.bioorg.2019.103226.
 LIU S S. Studies on the Constituents from Water Extract of Alismatis Rhizoma and Their Differences of Origins [D]. Beijing: China Academy of Chinese Medical Science, 2019 (in Chinese).
 CAI D L, YANG C Z, WEN X P, et al. Resource Investigation and Evaluation of Character for Alismatis Rhizoma [J]. Modern Chinese Medicine, 2016, 18 (2): 193 (in Chinese).
 LIU S S, GUO J, LI Z A, et al. Advances in studies on chemical compositions of Alismatis Rhizoma and their biological activities [J]. China Journal of Chinese Materia Medica, 2020, 45 (7): 1578 (in Chinese).
 MAKABEL B, ZHAO Y Y, WANG B, et al. Stability and structure studies on alisol A 24-acetate [J]. Chem Pharm Bull, 2008, 56 (1): 41.