Studies On The Preparation Technology And Quality Control Of Chushi Zhiyang Mixture

Purpose: Chushi Zhiyang Mistura is a Longhua-in-hospital prescription used in the treatment of actue eczema,which consists of eight kinds of traditional Chinese medicines.In this study,the preparation process and quality control of Chushi Zhiyang Mistura were systematically investigated,which would provide a theoretical basis for the development of new drugs.Methods: The study refers to the Chinese Pharmacopoeia of 2015 edition.Based on the transfer rate of baicalin,paeoniflorin and astilbin,the soaking time,quantity of water volume,the number of extractions and the extracting time were investigated to optimize extraction process using single factor and orthogonal experimental design.And then,the concentration process and purification process were identified by using the transfer rate of the three components and the solid content as the evaluation index.The formulation process and pilot-scale experiment were completed.In the quality control,Radix Scutellariae,Radix Paeoniae Rubra,Radix Rehmanniae,Flos Lonicerae,Poria cocos and Pericarpium Dioscoreae were identified by the thin-layer chromatography(TLC),and the high performance liquid chromatography(HPLC)was establish to determine the concentration of baicalin and paeoniflorin.Results: The optimal procedure conditions for Chushi Zhiyang Mistura was: the eight herbs were decocted together,soaked in water for 45 minutes,extracted twice with one hour every time,added 10 times water for the first time,8 times water for the second time,filtered and combined with two filtrates.The extraction solution was concentrated to the relative density of 1.03-1.05 g/m L tested in 75℃.Place it at room temperature,centrifuge,filter,and further concentrate the filtrate to the relative density of 1.11-1.13 g/m L tested in 75℃,and filter.0.3% of sodium benzoate and 0.025% of hydroxyphenylethyl ester were dissolved in appropriate amount of hot water and then added to the filtrate,stir well,filter,add water to 1000 m L,mix,fill(500 m L per bottle),sterilize.The relative density,pH value,and solid content of the batch No.1901001 Chushi Zhiyang Mistura were 1.09 g/m L,5.23,18.83%,respectively and the difference in the volume was in accordance with the relevant provisions of the Chinese Pharmacopoeia of 2015 edition.The six herbs of Astragalus,Radix Paeoniae Alba,Radix Rehmanniae,Honeysuckle,Earthworm and White Fresh Skin were identified by TLC,and the concentration of baicalin and paeoniflorin was determined by HPLC.The cconcentration of baicalin and paeoniflorin in the batch No.1901001 Chushi Zhiyang Mistura were 0.36% and 0.17%,respectively.The methods of quality control were strong specificity and good reproducibility.Conclusions: The study shows the preparation process for Chushi Zhiyang Mistura are reliable and practical,and the quality control can keep the drug quality under control.