Research On Quality Control Of Lianqiao Baidu Pill By Informatics

With the increasing popularity of traditional Chinese medicine(TCM)all over the world,TCM industrialization has ushered in a rare opportunity for development.The premise of realizing the industrialization of TCM is to vigorously develop the modernization of TCM and enhance its international competitiveness.But realizing the modernization of TCM,the old research pattern that is inherited from long-term practice.The key during the process is to break the fortress of the discipline and industry boundary and integrate the advanced ideas and techniques,which could serve for the research of the modernization of TCM.Twentyfirst Century,as a comprehensive information age of human society,data mining and data driven based on big data have become the mainstream mode on development of science and technology.For instance,in the process of modern research on TCM,how to deal with and mine the large amounts of data,and extract useful information from them,and search the laws behind the data and utilize them to guide the research on modern TCM,has become a problem to be solved by the Pharmaceutical Informatics workers.The paper is just based on this point and a Chinese patent medicine(CPM)-Lianqiao Baidu pill(LQBDP),which is composed of 19 common TCMs,is selected to be as the research object.During the process of experiment,multi-dimensional as well as multi-techniques combined with multi-chemometrics method,e.g.,principal component analysis(PCA),systematic cluster analysis(HCA),partial least square regression(PLS),pattern recognition(PR)and multivariate statistical analysis(MSA)were used to excavate and analyze the large amount of information and data in the analysis of LQBDP.The aim is to establish a reasonable,feasible and reliable method to control the quality of LQBDP preparations from the perspective of informatics.The main research of this paper are as follows:1.The HPLC digital fingerprint chromatograph(FPC)of 254 nm,278 nm and five wavelengths in series of LQBDP was established respectively,and then was evaluated by limit-ratio system fingerprint quantitative method(LRQFM),and the standardized digital HPLC fingerprint chromatographys(FPCs)and the reference fingerprint chromatography(RFPC)were established subsequently.Furthermore,the content of 15 kinds of makers in LQBDP samples was determined and the relationship between FPCs and quantitative results was analyzed by chemometrics.The results showed that the LRQFM,which was used to evaluate the TCM was scientific,simple and feasible.2.The optimal background electrolyte(BGE)is obtained by the triangular optimization method.With the optimum BGE,the capillary electrophoresis conditions(including pH,Voltage,extraction method of sample,and so on)were optimized.Thus,the HPCE digital fingerprint(FPC)of the 28 batch of LQBDP samples under 214 nm was established,and the LRQFM was adopted to evaluate the digital FPC from two aspects of the macro qualitative Sm and the macro quantitative Pm.Moreover,the quantitative analysis of 5 makers was performed.The relationship between digital FPC and the quantitative results was established by chemometrics.The results demonstrated two methods eatablished to control TCM quality were easy to operate,low cost of equipment,no organic solvents,environment-friendly green,pollution-free and good repeatability.It provides a good basis and reference for the quality control of LQBDP.3.Using the chemometrics,the relationship between the HPLC FPC of the 276 nm and the antioxidant activity of the 28 batch of LQBDP samples,as well as the relationship between the HPCE FPCs and the antioxidant activity in vitro were established,respectively,which provided drugs-effective information for the quality control of LQBDP.4.The preliminary analysis of the basis of the costitutuents in LQBDP samples was carried out with LC-MS/MS technology.The UNIFI natural product "TCM database" was used to analyze the fingerprint peaks in the total ion flow chart of LQBDP sample,and 24 compounds were identified finally,which provided the data supplement for the overall information quality control of the LQBDP preparation.With the above methods and steps,the quality of LQBDP is analyzed and evaluated from multi-dimension by diverse techniques.The results show that the established method is scientific,effective and stable.The methods can be used to control the quality of LQBDP preparation from the aspect of the informatics,and the methods established in this paper can also provide a scientific basis for the quality control of TCM.