Studies On The Quality Standards Of Alismatis Rhizoma And Quality Evaluation Of The Herbs Of Wuzhuyu Decoction

Part ? Quality standards of Alismatis RhizomaObjective: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.Methods:Based on herbal research,comparison of plant morphological characteristics and identification of DNA code,the source of Alismatis Rhizoma was revised;The contents of water,total ash,heavy metals and deleterious element,pesticide residues and alcohol-soluble extractive were analyzed according to the methods of Ch.P 2015 edition volume IV.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 mixture of dichloromethane-methanol?15:1?as a 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 246nm,respectively.Thirty-seven batches of crude drugs,thirty batches of prepared slices and nineteen batches of salted prepared slices of Alismatis Rhizoma were determined according to the established methods.Besides,the specific chromatograms were also established.The similarity evaluation,principal component analysis?PCA?and partial least squares-discrimination analysis?PLS-DA?were used to analyze the sample data.Results:The botanical sources of Alismatis Rhizoma could be revised as Alisma orientale?Sam.?Juzep.and Alisma plantago-aquatica Linn.in the Ch.P.2020 edition;Thin-layer identification was revised to use alisol B 23-acetate,alisol C 23-acetate and reference herbs to identify Alismatis Rhizoma;The extract content of salt prepared slices is revised to be no less than 9.0%;The revised content determination item is calculated based on the dried state,and the total content of alisol B23-acetate(C₃₂H₅₀O₅)and alisol C 23-acetate(C₃₂H₄₈O₆)should not be less than0.10%.The prepared slices and salt prepared slices are the same as the crud drugs.Combining the specific chromatograms and quantitative analysis of eight terpenoids,this study showed that the relative contents of components and their ratios were notable different in samples from different regions,but types and numbers of chemical compositions were basically similar.Conclusion:The quality standards established based on the research results were specific and repeatable,and suitable for the quality evaluation of Alismatis Rhizoma.The established characteristic chromatogramscould clarify the differences in the origin of Alismatis Rhizoma and its compositional characteristics.We recommended the botanical sources,TLC examination,alcohol-soluble extractive of salt prepared slices and content determination should be revised in the Ch.P.2020 edition.Part ? Studies on the quality evaluation of herbs of Wuzhuyu decoctionObjective: In order to provide basic information for the classic famous prescriptions Wuzhuyu decoction,each medicinal materials of Wuzhuyu decoction were collectd and evaluated in this study.Methods: By consulting the literature,investigating the main procuding areas of each medicinal materials of Wuzhuyu decoction,multiple batches of Euodiae Fructus,Ginseng Radix et Rhizoma,Zingiberis Rhizoma Recens and Jujubae Fructus were collectd,and they were determined according to the quality standards in Chinese Pharmacopoeia 2015 edition.Results: A total of 18 batches of Euodiae Fructus,15 batches of Ginseng Radix et Rhizoma,30 batches of Zingiberis Rhizoma Recensand 7 batches of Jujubae Fructus were collected from different procuding areas.Based on the determination of content and moisture,the batches of Euodiae Fructus,Ginseng Radix et Rhizoma and Zingiberis Rhizoma Recens conformd with the standard were all greater or equal to 15.Conclusion: The quality analysis of the four medicinal materials of Wuzhuyu decoction's prescriptions is an important part of Wuzhuyu decoction research and development,and it is a prerequisite for the subatance benchmarkers of Wuzhuyu decoction.This research has laid the foundation for the follow-up work.