Preparation process evaluation on the quality of Qiangxin Mixture based upon HPLC fingerprint and multi-component content determination
OBJECTIVE To establish the high performance liquid chromatography(HPLC)fingerprint of Qiangxin Mixture(QM)and determine the multi-component content and examine the effects of extraction,concentration,centrifugation and steril-ization on the quality of QM during preparation process.METHODS Extract,concentrate,centrifuge and mixture(after steril-ization)of QM were used as test products.And the fingerprints of four different process stages of preparation process of QM were established by HPLC and similarity evaluation and chromatographic peak identification performed.The contents of six compo-nents of quercetin-3-O-β-D glucose 7-O-β-D gentiandiglycoside,glucosine thiocyanate,glucosinoic acid,psyllin,isoflavone glu-coside and psyllin D were determined.RESULTS As compared with control fingerprint,the similarity of different process stages in the preparation of 10 batches of QM was greater than 0.90.It indicated that the production process was relatively stable and 18 common peaks in the extract increased to 21 after concentration,centrifugation and sterilization.The content determination results showed that different process stages of preparation process had varying degrees of influence on the quality of QM and concentration process had the greatest impact.CONCLUSION This study examined the effects of different preparation processes on the quality of QM and provided data and theoretical rationales for common techniques of overall quality evaluation during preparation pro-cesses of traditional Chinese medicines.