| Schisandra chinensis is magnoliaceae Schisandra chinensis dried ripe fruit.It has been recorded begining from" Shen Nong's herbal classic ",there are astringent,raising spirit and bodyfluid,invigorating the kidney and peaceful the heart effect.Schisandra chinensis contains lignans,volatile oil,organic acids and polysaccharides and other ingredients.The lignans is the main component of schisandrin chinensis,Schisandrin,schisandrol B,deoxyschizandrin,Schizandrin B and Schisantherin A are the main component of the lignans.Modern phytochemistry and pharmacology research indicated the lignans that riched in schisandrin chinensis,has the effect of lowering SGPT,enhance liver detoxification function etc,mainly used for liver disease treatment and health care,and has better clinical application value and development potential.The research takes the development of traditional Chinese medicine five drug(effective part extracted from natural medicine)as the goal,according to the State Drug Administration promulgtated the "Regulations for new drug approval".The main subject of study are the preparation process of total lignans in Schisandra chinensis,the quality standards of the total lignans in Schisandra chinensis,the stability of the total lignans in Schisandra chinensis and the preliminary effect of the total lignans in Schisandra chinensis.Concrete contents as follows:1.The preparation study of total lignans in Schisandra chinensisThe research using the content of total lignans in Schisandra chinensis,the extract yield and total lignans purity as index,screening of preparation process and influence factors.First to extract fluid total lignan content and extract yield was investigated indicators,selection of L9(34)orthogonal table experiments to study ethanol concentration,the amount of reflux time,frequency,and to determine the best extraction process,is crushed with 12 times amount of 80%ethanol,extracting for 2 times,each time 1.5h,through optimum extraction process validation experiments,this experiment to determine the process is reasonably practicable,operability.The purification process of total lignans in Schisandra chinensis,using a combination of single factor and orthogonal experiment method of Schisandra chinensis total lignanoids the purification process of macroporous resin,an optimal choice total lignans in Schisandra chinensis refining process:0.5 g/ml of crude drugs on the AB-8 macroporous resin,lBV/h flow rate of adsorption,the resin bed(?):L is 1:7,the optimum conditions of elution:first using water and 10%ethanol,30%ethanol,and 50%ethanol elution the eluate volumes are the amount of 6 times the column volume,after the removal of impurities eluting with 70%and 90%ethanol,the elution volume are 6 times the column volume,the eluent is decompressed and concentrated,vacuum drying to obtain the Schisandra total lignanoids extract,elution flow rate was 2BV/h.And technological parameters of preparing for the preferred by pilot test,can the transition to industrialization production.The three batch of pilot total content in the sample of 11 known lignans>50%,the total lignans transfer rate>60%.2.The standard quality research of total lignans in Schisandra chinensisThe research makes a deep research on the quality criteria of total lignans of Schisandra chinensis,including preparation,character,identification,examination,content determination.The identification,TLC identification method for reference to Chinese Pharmacopoeia 2010 edition,with a high content of samples and samples easy provided,use schisandrin,schisandrol B,deoxyschizandrin,Schizandrin B and schisandrin control medicine as control,to identified the total lignans of Schisandra chinensis;Determination of content study,analysis methods of using means such as HPLC,have conducted the thorough research to the total lignans of Schisandra chinensis quality standard element.Simultaneous determination of eleven lignans in total lignans of Schisandra chinensis,in investigation and the establishment of high performance liquid chromatography(Schisandrin,Gomisin J,Schisandrol B,Gomisin G,Schisantherin A,Deoxyschisandrin,Schisandrin B,Schisandrin C,angeloylgomisin H,schisantherin B,-schisandrin)method for determination of content,the results:eleven the measured lignans good separation;each component concentration and peak area showed a good linear relationship in the?range of determination(r>0.9995);reproducibility;accuracy;indicating that HPLC method proposed in this study is stable and reliable,simple and feasible,and can be used for quantitative analysis of total lignans in Schisandra at the same time.3.The preliminary stability study of total lignans in Schisandra chinensisThe room temperature sample investigation and accelerated stability test,the total lignanoids of Schisandra chinensis quality standards under the character,identification,examination,study of Schisandra lignans content determination,a preliminary investigation of the stability of the product,provide the basis for the preparation of safety,effective,controllable.4.The preliminary evaluation effects of total lignans in Schisandra chinensisEffects of total lignanoids of Schisandra chinensis in mice with acute hepatic injury induced by CCl4:the mice orally for 7 days to seventh days,1 hours after administration of molding,after 16 hours,blood and liver.Using automatic biochemical analyzer and the pathological section method of system evaluation of the protective effects of Schisandra lignans on acute liver injury in mice.The results show,total lignanoids of Schisandra chinensis have protective effects against acute liver injury in mice.Experimental study of total lignanoids in Schisandra chinensis anti lipid peroxidation caused by CCI4:mouse model of liver injury,the test can reflect the degree of lipid peroxidation malondialdehyde(MDA)content as the index,the Schisandra chinensis total lignanoids experiments,results show that,Schisandra total lignanoids have anti-lipid peroxidation the role of.This topic through the total lignanoids of Schisandra chinensis study on preparation process,optimization of a stable,controllable Schisandra chinensis total lignanoids preparation process,and carries on the study of quality standard,preliminary stability and effect evaluation,for further research and development of Schisandra chinensis lignans in new drug for the treatment of liver diseases lay a good foundation. |
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