Research On The Illegal Additives And Extraction Technology Of Niuhuang Jiedu Tablets

Objective：Research on the dynamic transfer rate of baicalin to provide a basis forformulating reasonable content limit.Make an review on quality control method ofNiuhuang Jiedu Tablets so as to establish an effective quality control system and avoid theoccurrence of illegal adding and guarantee drug safety, effective, and controllable. Theextraction technology of Niuhuang Jiedu Tablets was studied to establish reasonableprocess parameters and provide reference for drug manufacturers.Methods：HPLC was used to determine the content of Baicalin in every intermediateproduct and calculate the transfer rate. HPLC-FLD was applied to detect the rhaponticinillegally mixed in Niuhuang Jiedu Tablets.A gradient mobile system was applied in theexperiment.The fingerpr ints of different samples were compared with simlarity evaluationsoftware published by comm ittee of codex7.Establish a RP-HPLC met hod for thesimultaneous determination of baicalin, baicalein and wogonin in Niuhu ang Jiedu Tablets.Orthogonal design was applied to investigate the optimum water extraction process ofNiuhuang Jiedu Tablets with baicalin and glycyrrhizic acid as marker.Results：Baicalin limit was on the low side in current standard, and can’t controlquality of Niuhuang Jiedu Tablets availability. Rumex glycoside was checked positivly ineight samples. The similarity was correlated with the habitat of the samples.Seven peakswere identified as the characteristic fingerprints of Niuhuang Jiedu Tablets. All samplestested contained the same eight peaks, but the content of each peak showed great differenceamong the samples, which resulted in the differences on their chromatograms.Samplesfrom different manufacturers have significant difference in the content of baicalin,baicalein and wogonin.Significant differences was found between water and alcohol extractionprocess and the alcohol extraction was obviously prior to water extraction.Conclusions：The dynamic transfer rate research provides certain reference for theformulation of baicalin limit standard. The HPLC-FLD method is simple, efficient, goodrepeatability and can be used as the determination of rumex glycosides in Niuhuang JieduTablets.Study on the characteristics of fingerprint can briefly and effectively assess thequality of Niuhuang Jiedu Tablets with multicriteria and multicomponent. Alcoholextraction was prior to water extraction, which used in the production process needs furtherstudy. But the extraction parameters can provide technical support for manufacturers.