Alkaloids In Rhizoma Corydalis And The Application Study On Quality Control Of Yuanhuzhitong Tablets

OBJECTIVE: The present study is to establish the separation of alkaloids method inRhizoma Corydalis, and a measurement to test the content of4kinds of alkaloids inYuanhuzhitong tablets in order to improve the quality evaluation of Yuanhuzhitong tablets.METHOD: Based on the objective of the present study, we first collect the relevantliterature of Corydalis yanhusuo W. T. Wang. Isolation and purification of alkaloids fromRhizoma Corydalis by silica gel column chromatography, high-speed counter-currentchromatography and semi-preparative high performance liquid chromatography. Thestructures of the compounds were identified by ESI-MS and NMR. Then amulti-assessment method to measure the quality evaluation of Yuanhuzhitong tablets wasset up. In order to establish a new method of quality evaluation and validate its feasibilitiesby the simultaneous quantitative assay in Yuanhuzhitong tablets, the new qulity evaluationmethod, quantitative analysis of multi-components by single marker (QAMS), wasestablished and validated with Yuanhuzhitong tablets. We used tetrahydropalmatine,tetrahydroberberine, d-corydaline and dehydrocorydaline as analytes to evaluate the quality.Then10batches of samples, collected from different drug markets, were determined byboth external standard method and QAMS and found no significant differences betweenexternal standard method and QAMS. After compared the results of external standardmethod evaluation with a multi-method test results, QAMS is feasible and suitable toevaluate the quality of Yuanhuzhitong tablets. RESULTS: With the method of silica gel column chromatography, high-speedcountercurrent chromatography and semi-preparative high performance liquid chromatography.5alkaloids were successfully isolated from Rhizoma Corydalis. All of these compoundswere elucidated as glaucine, tetrahydropalmatine, tetrahydroberberine, d-corydaline,dehydrocorydaline. We measured using a multi-assessment method and external standardmethod for the determination of the10batches of Yuanhuzhitong tabletstetrahydropalmatine, tetrahydroberberine, d-corydaline, dehydrocorydaline. the testshowed that no significant difference between the two methods.CONCLUSION: The research work and the results obtained, and further improve thequality evaluation of Yuanhuzhitong tablets, and improve the quality standards ofYuanhuzhitong tablets reference.