Study On Preparation Technology And Quality Standard Of Classic Formula Xiebaisan

Objective: The preparation technology of Xiebaisan substance benchmarks was following original methods,including particle size of “Cuo san”,soaking,heating method and time,solid-liquid separation,concentration and drying,etc.And 15 batches of Xiebaisan substance benchmarks were prepared.The substance benchmarks quality standard of Xiebaisan was established,including TLC,content determination,fingerprint,dry extract rate,moisture determination,extract determination,etc.And 15 batches of the Xiebaisan substance benchmarks was determined.Methods: The preparation process of Xiebaisan substance benchmarks,such as particle size of “Cuo san”,soaking,heating method and time,solid-liquid separation,concentration and drying,was investigated with the dry extract rate,content determination of glycyrrhizin and glycyrrhizic acid,and fingerprint as evaluation indexes,and the process verification was carried out.The TLC method was used to establish the TLC identification of Xiebaisan substance benchmarks,the HPLC method was used to establish the content determination of glycyrrhizin and glycyrrhizic acid and fingerprint,the moisture determination method and the extract determination method were respectively used to determine the moisture content and extract.Results: The best preparation technology of Xiebaisan substance benchmarks is Mori Cortex 41.3 g,Lycii Cortex 41.3 g and Glycyrrhizae Radix et Rhizoma 4.13 g,smash through the first sieve respectively,add 10.5 g of japonica rice,1260 mL water in 3L tisanes pot,the high heat heated to boiling after soaking for 10 minutes,slow fire to keep boiling for 15 minutes,solid-liquid separation with 100 mesh filter cloth and enrichment to about 200 mL under 60℃,freeze drying(T<-40℃,Vac<20Pa)to obtain substance benchmarks.In TLC identification,the reference materials of Xiebaisan substance benchmarks showed the same color spots in the same position as the reference medical material.The transfer rates of glycyrrhizin and glycyrrhizic acid were within ±30%.The similarity of fingerprint was greater than 0.9.The dry extract rate,moisture content and extractives were all within the mean±30%.Conclusion: The preparation technology of Xiebaisan substance benchmarks was stable,reliable and reproducible.The quality standard can control the quality of Xiebaisan substance benchmarks in a comprehensive way and provide reference for the research of Xiebaisan formulation.