| Objective To establish a qualitative and quantitative method for the analisis of Sanzisan in ivitro based on the pattern that use fringerprint combined with Quantitative Analysis of Multi-components by Singal Marker(QAMS) to control the qualiy of mongolia medicine,the objective was to build a comprehensive quality control method of Sanzisan.To bulid the fingerprint of Sanzisan in rat serum and study the blood constituents of Sanzisan based on the theory of Serum pharmacochemistry.Methods(1)To establish a fingerprint of Sanzisan with repeatablity,precision and stibility have been done to verify the mothod.(2)To establish the method to detrmine 7 components of Sanzisan(gallic acid,gardenoside,chlorogenicacid,genipingentiobioside,geniposide,crocin-I,crocin-?)once time with Quantitative Analysis of Multi-components by Singal Marker(QAMS).The relative correction factors(RCF) of other components were calculated with geniposide used as internal reference.The RCF Were tested with two different HPLC instruments and three different columns.The relative error evaluation was used to evaluate the result of QAMS and external standard method if they have significant difference.(3) To build the fingerprint of Sanzisan in rat serum.Repeatablity,precision and stibility have been done to verify the mothod.(4)The Sanzisan rat serum was determined to affirm the blood constituents of Sanzisan and the source of blood constituents.Results(1) The HPLC fingerprint analytical method was established,31 common peaks were distinguished, compared with the reference sustance and confirmed that No.3 peak was gallic acid,No.10 peak was gardenoside,No.14 peak was chlorogenic acid,No.16 peak was genipin gentiobioside,No.17 peak was geniposide,No. 24 peak was chebuligic acid,No.28 peak was crocin-I,No.29 peak was crocin-?.1(2) The QAMS method was bulid to determine 7 contents of Sanzisan,with geniposide used as internal reference,the RCFof the other 6 contents were confirmed,the RSD of each RCF tesed in different instruments and columns were <5%;determined 10 batches of Sanzisan with both QAMS method and external standard method,the results determined by two methods were compared with relative error evaluation and which were lower than 5%.(3) The analytical method of fingerprint of Sanzisan in rat serum was established.5(4)20 constituents were absorbed in resum,among which 9 constituents were origonal compounds and the other 11 were metabolites.The source of the blood constituents were confirmed.Conclusions(1) Established the fingerprint of Sanzisan,the resule showed that retention time of different batches of sample were stable,the HPLC stacking atlas were samed with the analysis result of similarity,the results shoued that the analysis conditions of fingerprint were suitable foe the quality control of Sanzisan.(2)The QAMS method was bulid to determine 7 contents of Sanzisan,the methodological evaluation,accuracy and durability test were usde to vertify the method,the consequence was that the result of external standard method ang QAMS didn't have significant difference,the QAMS method was suitable for the quality of Sanzisan.(3)The fingerprint of Sanzisan in rat serum was established,the result showed that retention time of 5 batches of sample were stable and had high similarity,the method that suitable for the quality control of Chinese-Mongolian medicine which have complicated component can also be used to the study of Serum pharmacochemistry of Chinese-Mongolian medicine,bacause the fingerprint in rat serum can reflect commonality of blood constituents inevitably.(4)20 constituents were absorbed in resum,among which 9constituents were origonal compounds and 5 constituents were confirmed(gallic acid,gardenoside,genipin gentiobioside,geniposide,crocin-I),the result laied the fuundation for the reserch of efficacy material base of Sanzisan;Some contents can be absorbed in the serum only when both three or two herbs were exist,its showed that the 3 herbs in Sanzasan were play a role rogether. |
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