| The standardized research in quality of traditional Chinese medicinal materials andits preparations is the essence to ensure the quality, it is also the only way to achieve modernization of traditional Chinese medicine. In the course of studying quality of traditional Chinese medicinal materials and developing new drug, only by using advanced technique method, launching the study of quality standard systematic comprehensively and objectively, can our knowledge be improved and developed during experiments.Objective: To formulate quality standard of Fructus Corni for manufacturer. The contents include identification determination, determination of water and ash comparison of variety determination of collection period and so on. Further, to carry out quality standard of new drug named Fructus Corni tablet, the contents include TLC determination of content and so on.Methods: 1. Determining water content ash content and ash content insoluble in acid of Fructus Corni.2..The study on TLC differentiating: As ursolic acid to be target, experimental study of TLC to differentiate Fructus Corni is carried on, selectiong of abstract solvant, lasting time of abstracting and capacity of sample drop have been compared respactivly. Before we decide the optimal condition .As ursolic acid astragaloside I asiaticoside, rhein, emodin and chrysophanol to be targets, experimental study of TLC to differentiate Fructus Corni tablet is carried on; Conditions and methods of extraction and isolation elute and sensitivity areoptimized and selected separately, corresponding TLC is established; The sole experiment of discrimination method for Fructus Corni is carried on by using deficient sample.3.The study on content determination : As ursolic acid, loganin to be targets, experimental study of determining content by HPLC for Fructus Corni is carried on. To improve the method on the conference, add certain proportional HAC in the elute, to better the shape of peak, and optimize the abstract condition of sample solution. The content of ten batches of Fructus Corni sample which provided by medicinal materials' manufacturer is determined by HPLC, which are compared with by using high performance liquid chromatograph and dual-wavelength thin-layer chromatograph scanner in order to test and verify the feasibility of determining content by HPLC.As ursolic acid asiaticoside rhein emodin and chrysophanol to be targets, experimental study of determining content by HPLC for Fructus Corni tablet is carried on; Experimental study are separately carried on for optimal selection on chromatographic conditions which include selection of elute and wavelength , the preparing of sample to be determined which include reagent for extraction and conditions for isolation and purification, meanwhile, systematic experimental study of method is carried on and takes advantage of deficient sample, the sole experiment of method for Fructus Corni is carried on and the corresponding HPLC method for determining content is established.4.The application of mathod: the sample content of different varieties is compared with t o p rovide e xperimental b asis for s electing t he b est s pecimen; T he c ontent o f Fructus Corni fruits of mature periods is dynamic monitored to provide experimental basis for determining the best collection period.Ingredients of every target in Fructus Corni are determined and limitation of content is established.Results: Quality standard of Fructus Corni includes: As ursolic acid to be target, TLC is established and deficiency doesn't matter. Ursolic acid content shouldbe no less than 0.25%,loganin content no less than 0.7% water content no more than 18% ash content no more than 8% among which ash content insoluble in acid no more than 3%. The content of Fructus Corni fruits of different mature periods which is dynamic monitored shows: as ursolic acid to be target, the content appears trend of descending gradually, but during the collection period of medicinal materials, the content is still exceed t he 1 imitation c ontent fixed... |
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