| The overall effect of traditional Chinese medicine and multi-component,multi-pharmacodynamic characteristics determine any single component as the indicators are not accurately reflect the quality of Chinese herbal medicine,Chinese Herbal Medicine.Establishment of Chinese medicine quality assurance system should have the characteristics of traditional Chinese medicine,the establishment of a multi-component,multi-mode quality control indicator,the overall efficacy of traditional Chinese medicine and its preparation can be controlled.Schisandra chinensis fruits are the dried ripe fruits of Magnoliaceae Schisandra chinensis(Turcz.)Baill.with an effect of nourishing the liver and heart and other effects.Schisandra Health specializes in the treatment of cough medicine,cooked with vinegar enhance the role of protecting the liver.Currently,only the determination of the content of Schizandrin to control the quality of Schisandra medicinal herbs and slices.The topics to unprocessed and vinegar processed schisandra for the study,with the Chinese Pharmacopoeia standards for the quality of the direction of development-oriented representatives,establish HPLC fingerprints of unprocessed and vinegar processed schisandra,establish a quantitative detection method of multi-component lignans and "Quantitative analysis of multi-components by single marker"quality evaluation model,and study the establishment of a control method for preparing lignan extract to provide a scientific basis for quality evaluation of unprocessed and vinegar processed schisandra.The main contents are as follows:1.HPLC fingerprint of unprocessed and vinegar processed schisandra were established.10 batches schisandra and 10 batches vinegar Schisandra were collected from different areas.14 common peaks were demarcated by using the Chinese Pharmacopoeia Commission recommended "chromatographic fingerprint evaluation system" software(2004A version),which were method validation,precision,stability and reproducibility were good.And by comparison with traditional Chinese medicine chemical markers of retention time,confirming the eight common peaks.By similarity evaluation,the similarity of 10 batches of medicines were greater than 0.9;similarity of 10 batches of vinegar Pieces were also greater than 0.9,and the retention time is stable,indicating that students created,vinegar Schisandra fingerprints also has good stability and controllability and can be used as the basis for one of Schisandra quality evaluation.2.Study established a method for the simultaneous determination of HPLC analysis of Schisandra 8 lignans,the chromatographic conditions were as follows:AkzoNobel-Kromasil C18 column using a mobile phase of acetonitrile(A)-water(B),with gradient elution(0～30 min,51%A;30～60 min,51%A → 80%A;60～70 min,80%A →51%A),a flow rate of 1.0 ml · min-1,the detection wavelength was 217 nm,column temperature 30℃,the injection volume was 10 μl.By methodological study,precision,stability,repeatability and accuracy are met,eight lignans in the same chromatographic conditions good separation.3.Study established schisandra and Pieces," Quantitative analysis of multi-components by single marker " quality evaluation model to Schizandrin as an internal matter relative calibration factor seven other ingredients are fschisandrin/Gomisin J =1.13,fSchisandrin/Schisandrol B=1.03,fSchisandrin/Gomisin G=0.86,fSchisandrin/Schisantherrin A =0.85,f Schisandrin/Deoxyschisandrin ＝1.04,fSchisandrin/Schisandrin B=1.09,fSchisandrin/Schisandrin c=1.03.By correlation coefficient,pearson correlation coefficient,cosine similarity value of three evaluation methods,showed a high similarity between the external standard method and a multi-measure assessment method,while the relative error and the relative deviation less than 3%no significant differences between the two methods show.In relative calibration factor durability study,different column sizes,different brands of high-performance liquid chromatograph smaller relative standard deviations were less than 3%,indicating that the establishment of the correction factor has good durability.Positioning peak retention time difference and examine the relative retention time of two parameters,the final choice of using the relative retention time positioning.The relative retention times are RT Gomisin J= 1.2,RTSchisandrolB =1.3,RTGomisin G=2.4,RT Schisantherrin A=2.9,RT Deoxyschisandrin =4.6,RT Schisandrn B=5.3,RT Schisandrin C =5.5,Combined with various chromatographic peak type and UV absorption characteristics,able to correctly determine the exact position of the Target peak.4.Using ethanol extraction and macroporous enriched Schisandra lignans,respectively,based on 70%,90%ethanol eluted in different parts of silica gel column chromatography,semi-preparative liquid chromatography separation techniques from the CCP got 4 monomer component,through physical and chemical properties,1H-NMR and 13C-NMR spectroscopy were identified as Gomisin J(compound 1),Schisantherin B(compound 2),Aneloygomisin H(compound 3)and Gomisin D(compound 4).By comparing the retention time and UV absorption characteristics of a compound can be determined as Schisandra fingerprints of peaks in the 2nd unrecognized,compound 2 is the peak on the 5th,the peak on the 9th of compound 3,compound 4 is the 11th peak,and these four components in Schisandra higher levels,provide a reliable scientific basis for the comprehensive evaluation of Schisandra quality.5.Study established a process for preparing lignans control extracts,todetermine the elution solvent,elution rate,elution volume,higher than the optimum process parameters such as diameter,the next step is also necessary to control Schisandra extract each component structural identification.Through these studies,this study not only established a unprocessed,vinegar processed Schisandra HPLC fingerprint,Determined the detection method for simultaneous determination of Schisandra 8 lignans,and establish of quality evaluation model of schisandra and Pieces,"Quantitative analysis of multi-components by single marker",Schisandra extract control and a preliminary exploratory research,provides a method based approach for the control and evaluation of comprehensive health,quality vinegar Schisandra and also provides a new quality research guideline for Chinese Herbal Medicine. |
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