Study On Preparation And Quality Evaluation Of Standard Salvia Miltiorrhiza And Wine-processing Salvia Miltiorrhiza Decoction Pieces

This paper conducted a series of studies on standard Salvia Miltiorrhiza decoction pieces for Preparation Specification.Standard decoction pieces is a qualitative control substance in the process of study on quality,which is similar to the control of chemical drugs and the Chinese herbal medicine compared.Its applications could identify the authenticity of decoction pieces more accurately.Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza decoction pieces were used commonly in clinic,which belongs to dry root and rhizome of Salvia miltiorrhiza Bge.This article selected standard Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza decoction pieces to research preparation and quality evaluation critiria for a qualitative control substance in quality control.Firstly,we must determine the source of raw materials.Through research,we knew that the end of October was harvest time,County Pingyi of Linyi was best collecting area and Sun-Dried method was best processing method.Choosing three batches of Salvia Miltiorrhiza from pieces enterprises for processing,we could get Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza decoction pieces.Secondly,we must knew the praperating technology.This paper was adopted to investigate the influence of crushing methods,crushing equipment and grinding parameters on praperating technology using the physical appearance of powder,particle size distribution,uniformity of particle size distribution and stability of the powder store as indexes.Results:The optimized praperating technology was as follows as drying ground,variable speed high speed grinder,speeding 6000r·min-1,1.0mm mesh,reset.Finally,we studied on the quality standard.Using modern scientific methods and according to the Chinese Pharmacopoeia of2015 edition,the moisture,ash,extract,etc were checked.using microscopic identification and TLC method to identify,the limits of standard Salvia Miltiorrhiza decoction pieces were set as follows:the moisture,total ash and acid insoluble ash should not be over 13%,10% and 2%,respectively.Pb,Cd,As,Hg,Cu should not be over 5mg·kg-1,0.3mg·kg-1,2mg·kg-1,0.2mg·kg-1,20mg·kg-1,respectively.Water-soluble extract,ethanol soluble extraction should not be less than 35%,11%,respectively.The contents of tanshinones and salvianolic acid B should not be less than 0.25%,3.0%,respectively.The moisture of standard wine-processing Salvia Miltiorrhiza decoction pieces should not be over 10%,and the other standards were same as that of standard Salvia Miltiorrhiza decoction pieces.This paper also established a head-space capillary GC method for the determination of ethanol residue in wine-processing Salvia Miltiorrhiza.Separation was carried on an HP-5 capillary column with the oven temperature 20℃.Temperature of injection inlet was200℃ and that of FID was 250℃.Carried gas was nitrogen at a flow rate of 5.0mL·min-1.Split ratio was 10:1.Headspace vials were balanced at 90℃ for 30 min,and the injection time was 1 min.Thealcohol content of radix salviae miltiorrhiae should not be less than 0.2%.The developed method is convenient and reproducciblein in identification of Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza.At the same time,HPLC was used to study the fingerprint of 9batches of standard Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza decoction pieces.The HPLC method was used with Welch-C18 column(250×4.6mm,5?m),under the wavelength of 270 nm with 20℃ of column tempereture and 10?L of injection volumn.A linear elution of acetonitrile-0.1% phosphoric acid solution was adopted at the flow rate of 1 mL·min-1:0~15min,10%~17%acetonitrile;15~18min,17%~25%acetonitrile,18~36min,25%~30%acet onitrile;36~39min,30%~57%acetonitrile;39~48min,57%~61%acetonit rile;48~53min,61%~70%acetonitrile,53~58min,70%~75%acetonitrile;58~65min,75%~90%acetonitrile;65~70min,90%~10%acetonitrile.This condition could make the characteristic components of Salvia Miltiorrhiza such as Salvianolic acid B,tanshinol,RosA,TanshinoneⅡA,TanshinoneⅠand DihydrotanshinoneⅠseparate better and shown in the chromatogram.Through preparing the standard Salvia Miltiorrhiza and wine-processing Salvia Miltiorrhiza decoction pieces,we could know their attributes which were different from the original medicine in general and to ensure the safety,effectiveness and controllability more exclusive.