Study On Quality Standard And Extraction Technology Of BUDDLEJAE FLOS

Objectives:The research aimed to through systematic quality standard study to compensate for the defects of early quality standards of BUDDLEJAE FLOS and provided basis for BUDDLEJAE FLOS quality control system, which conforms to modern Chinese medicine specification and science&technology standard. Besides used the orthogonal test to optimize the extraction condition of the BUDDLEJAE FLOS in order to lay the foundation for the drugs pharmaceutics.Methods:Quality standard study of BUDDLEJAE FLOS:1, Collected22batches of BUDDLEJAE FLOS for preliminary identification and built up the TLC method and the "moisture" and "ash" limits.2, Developed the reversed phase HPLC method for the simultaneous determination of acteoside and linarin, the representative composition in BUDDLEJAE FLOS.3, Explored and built up the fingerprint of BUDDLEJAE FLOS and combining with origin information and content determination, evaluated the quality of BUDDLEJAE FLOS through related softwares.Optimize extraction technology of BUDDLEJAE FLOS:Got the preliminary screening extraction conditions through the single factor experiment, arranged and carred out the orthogonal test by using representative active ingredients——acteoside and linarin as the dual-indexes to optimize the extraction condition of BUDDLEJAE FLOS.Results:1. Established the TLC qualitative identification method:22batches of BUDDLEJAE FLOS samples showed deep blue spots with good separation and moderate Rf value in the corresponding position as the reference substance did. Found the "moisture","ash" limits and suggested the "moisture" and "ash" content lower than10%,8%, respectively.2. Established the HPLC method to determinate the representativly active ingredients of acteoside and linarin simultaneously. The methods were simple, rapid, and reliable. The contents range of acteoside and Linarin were0.59%～4.62%,0.52%～1.23%, respectively.3. Built up the fingerprint of BUDDLEJAE FLOS. Fingerprints were measured by similarity analysis, Hierachical clustering analysis and princirpal components analysis, and all the analysis were tend to coincident. And quality evaluation is basically identical with pharmacognosy research and content determination.4. Optimized the extraction technology of BUDDLEJAE FLOS. The optimal extraction technology was to extract for two times with10fold ethanol solution (60%),45minutes for the first time and8fold ethanol solution (60%),30minutes for the second. The optimal extraction technology is rational and stable. Conclusions:In this paper, through further qualitative and quantitative study, including traits study, TLC qualitative study,"moisture" and "ash" limit study, content control and fingerprint study, supplement and perfect the quality standards of BUDDLEJAE FLOS. The established quality evaluation method is simple, scientific and reliable and can comprehensively assess the quality of BUDDLEJAE FLOS. Meanwhile, optimized extraction technology of BUDDLEJAE FLOS, which is energy-efficient, reasonable and reliable, and can lay the basis for the drugs pharmaceutics.