Quality Analysis Of Fructus Schisandrae Chinensis And Pharmacokinetics Research Of Its Lignan

Fructus Schisandrae Chinensis is a commonly used traditional Chinese medicine. Since Fructus Schisandra Chinensis has better pharmacological effects than Fructus Schisandra sphenanthera,many researchers are trying to study the quality evaluation methods as well as pharmacokinetics of Fructus Schisandra Chinensis.This present study focused on the lignan,a kind of major active components in Fructus Schisandra Chinensis.Several high-performance liquid chromatography(HPLC) methods have been established for quality evaluation ofFructus Schisandra Chinensis and relative products Tangke Capsule.Large volume injection(LVI) used in gas chromatographic(GC) analysis can improve the sensitivity when trace sample components determined at very low concentration levels.This technique is always used in pesticide residue analysis and environment pollution analysis.Up to now,there is no literature about LVI used in pharmacokinetics research.For the first time,an approach for determination of several lignan components in rat plasma has been developed by large volume injection gas chromatography coupled with mass spectrometry(LVI C-C/MS).The established method has been successfully applied in pharmacokinetic study of lignan in rat plasma after single oral administration of Tangke Capsule.The main contents are described as follows:Firstly,the method for quality control of Fructus Schisandra Chinensis has been studied.A HPLC method was developed for fingerprinting analysis and simultaneous quantification of four lignan components(i.e.schisandrin,schisantherin A, deoxyschizandrin andγ-schisandrin) in Fructus Schisandra Chinensis.The method was simple,accurate and reproducible.Using cluster analysis to characterize fingerprinting data could classify Fructus Schisandra Chinensis and Fructus Schisandra sphenanthera distinctly.Secondly,the quality evaluation method of Tangke Capsule has been studied.A HPLC method for simultaneous determination of schisandrin,gomisin A, angeloylgomisin H,deoxyschizandrin andγ-schisandrin has been established.The validation data indicated the method was simple,sensitive,accurate and reproducible. This method can be used for quality control of Tangke Capsule.Thirdly,the method for determination of several lignan components in rat plasma has been studied.For the first time,a LVI C-C/MS based method has been established for determination of four lignan components in rat plasma.Subsequently,it was applied in pharmacokinetic study of Tangke Capsule.Attributed to the technique of LVI by programmed temperature vaporization,sample preparation was simplify and the sensitivity was improved.The limits of detection(LOD) of deoxyschizandrin,γ-schisandrin,schisandrin and angeloylgomisin H in rat plasma were 0.855,0.473, 2.10 and 1.81 ng·mL^-1,respectively.The method was simple,special,sensitive and reproducible.The result of pharmacokinetic study indicated that:the rate of absorption and elimination of schisandrin and angeloylgomisin H was fast,the average T_maxwas 3.3±1.9 and 3.3±1.5 h,the average T_1/2 was 1.26±0.06 and 1.70±0.16 h.The AUCs curve of schisandrin and angeloylgomisin H for two rats had double absorption peaks.The rate of absorption and elimination of deoxyschizandrin andγ-schisandrin was slow,the average T_max was 5.0±1.1 and 5.5±0.5 h,the average T_1/2 was 3.28±0.58 and 4.82±0.55 h.