The Study And Application Of The Preparation And Quality Evaluation Of Corydalis Reference Extract

As a kind of traditional Chinese medicine standard material,traditional Chinese medicine reference extract could comprehensively and scientifically evaluate the quality of medicinal materials.Compared with the reference substance,the reference extract with an easier preparation,lower price and better stability,could remarkably reduce the use of the monomer reference substance and the rare resources of traditional Chinese medicine,also saved the test cost at the same time.Compared with the control herbs,the reference extract without pre-processing links was easily operated.Since Pharmacopoeia recorded less species of traditional Chinese medicine reference extracts,the research and development of them was promising.In recent years,there were many researches and progress on the origin,chemical composition,pharmacological effects and quality standards of Corydalis yanhusuo,but studies and applications of the preparation and quality evaluation were few.ObjectiveThis paper mainly studied in the preparation process of Corydalis reference extract,aimed at establishing a quality standard,applying Corydalis reference extract to the quality evaluation of Corydalis yanhusuo herbs(including decoction pieces)and Chinese medicine preparations,then providing a reference for groping the quality evaluation model which took traditional Chinese medicine reference extract as standard substance.MethodsAn HPLC method was developed for the determination of various alkaloids in the Corydalis yanhusuo extract.Gradient elution was used by C18 AQ(250 mm×4.6 mm,5.0?m)column in the study of preparation process of Corydalis reference extract,the mobile phase was acetonitrile-0.1%phosphoric acid(adjust to pH 6.1 by triethylamine),the detection wavelength was 280nm and the column temperature was 30?.Prepared the extract of Corydalis yanhusuo for qualitative and quantitative analysis,then established the quality standard of extract,and used it as the reference substance to determine the contents of many components in the medicine and its preparation.ResultsThe preparation process of Corydalis yanhusuo extract was determined by optimizing the extraction,purification,concentration and drying process.Six batches of Corydalis yanhusuo extract containing 60%known alkaloids were prepared.Established an HPLC fingerprint method for content determination of 9 alkaloids in Corydalis yanhusuo.The quality evaluation of extract including thin layer identification,content determination and fingerprints were studied,and the draft of Corydalis yanhusuo extract quality standard was established.The extract was applied to the thin layer identification which was associated with rhizoma Corydalis yanhusuo,and the results of them were consistent with control herbs.Corydalis yanhusuo extract was also applied to the contents determination of Corydalis yanhusuo herbs(including decoction pieces)and formula particles,and the difference was small compared with those measured in the chemical control.The results showed that the evaluation method which used Corydalis reference extract as the reference material was scientific and comprehensive,and it should be perfected and popularized.ConclusionApplied Corydalis reference extract in place of the single reference substance and control herbs to comprehensively evaluate the quality of Corydalis yanhusuo,and provided the basis and reference for the quality evaluation model which used traditional Chinese medicine as the reference substance.