Study On The Substance Benchmarks Of The Classic Formula ShaShen MaiDong Decoction

Objective To prepare the substance benchmarks of Shashen Maidong Decoction;To establish a Characteristic Spectrum method and a TLC method of substance benchmarks,and establish the analysis method of glycyrrhizin by using HPLC.To prepare 15 branches of Shashen Maidong Decoction and detect the anointment rate,moisture,and leaching.To analyze the Characteristic Spectrum,content determination and TLC of 15 batches of substance benchmarks.To attribute the peaks as a result of Characteristic Spectrum.The aim is to create a certain theoretical foundation for the quality research of the substance benchmark of Shashen Maidong Decoction.Methods Preparation process research According to the "Item Differentiation of Warm Febrile Diseases " and "Opinions of Chinese Medicine Classic Compound Preparation for Simplifing the Registration and Approvaling Management Regulations and Declaration Information Requirements",in accordance with the "original composition,original dose,original preparation method" principle,use casserole for frying,the frying liquid after concentration is used for spray drying,andfinally get 15 batches of substance benchmarks of Shashen Maidong Decoction.Quality standard research Using TLC method and HPLC method to establish thin layer identification method,Characteristic Spectrum and content determination method of substance benchmarks and analyze 15 branches of substance benchmarks.And determine the anointment rate,moisture,leaching and content,Transfer rate.Result Preparation process research Refer the conclusions of single factor test before,the preparation method of the substance benchmarks is: steep the medicine for 30 minutes after adding Glehniae radix 22.50 g,Ophiopogonix radix 22.50 g,Polygonatiosoratirhizoma 15 g,trichosanthis radix 11.25 g,Mori folium 11.25 g,Lablab semen album 11.25 g and Glycyrrhizae radix et rhizoma 7.50 g into a electric earthenware pot with 3000 m L water.Wu-fire boil for 80 minutes,filtering,get water frying liquid 1200 m L,decopression concentrate(50℃)to 400~600m L,spray drying(inlet temperature 140 ℃,intake 100%,peristaltic pump speed 22 rpm),and finally collect dry powder.Quality standard research The TLC test method of Polygonatiosoratirhizoma and Glycyrrhizae radix et rhizoma was established.The method is convenient.The spots in result is clear and the negative samples have no interferences;The method of Characteristic Spectrum was established and 20 chromatographic peaks was marked,in which 2 chromatographic peaks was identified,one was glycyrrhizin(peak 8)and the other was liguiritin(peak 17).Reguard peak 8 glycyrrhizin as reference,the similarities of 15 branches substance benchmarks were high and greater than 0.9.The attributions of 20 chromatographic peaks showed that these peaks were mainly from trichosanthis radix,Mori folium and Glycyrrhizae radix et rhizoma.The other chromatographic peaks were communal;The results of exclusion,the precision of the instrument,the repetition of the samples,the intermidiate precision,durability and the recovery rate are all qualified.The recovery rate of glycyrrhizin was between91.07%~109.48%,which met the requirment.The content range of glycyrrhizin in 15 branches of substance benchmarks was 0.053%~0.478%.The transfer rate of glycyrrhizin ranged from 38.92% to 60.98%,whose average is 50.02%,and it didn’t show a discrete data(70%~130% of the average);The aniontment rate in 15 branches of substance benchmarks was 27.79%~38.68%.The average aniontment rate was34.12%,which didn’t show a discrete data(70%~130% of the average).The moisture was 4.28%~6.28%.The average moisture was 5.16% that didn’t show a discrete data(70% to 130% of the average).The content of leachate was 17.15% to 27.48%.The average leachate content was 22.15% and didn’t show a discrete data were present(70% to 130% of the average).Conclusion In this study,the substance benchmarks of Shashen Maidong Decoction were prepared.The methods of TLC,Characteristic Spectrum and content determination were established,which were convenient and accurate.For these study,it can support the deep researches of Shashen Maidong Decoction.