Yuxianling Spirit Particles Pharmacy

Objective:Yuxianling Granule,which is made from Rhizoma ChuanXiong,scorpion, Scolopendra and other five kinds of herbs,is an effective prescription in preventing and treating epilepsy.The auther has made a systematic study on its preparation,quality standards and stability.Methods:(1) The extraction process of three kinds of herbs with volatile oils was evaluated by the weight of essential oil;The percentage recovery of inclusion compound,transfer rate of oil,inclusion rate of oil as indexes,the inclusion process withβ-CYD was evaluated.(2)With the amount of extraction, the contents of ferulic acid and baicalin in the liquid of extraction as indexes, the extraction process was selected by muti-index test breakdown formula evaluation combined with orthogonal design method;With the content of ferulic acid as an index,Different drying ways were studied on the identical concentration liquid.(3)The amount of extract and total nitrogen content were used to evaluate the alcohol extraction procedure by orthogonal design method. (4) To screen better excipient and better ratio of the excipients and to improve the formability of the Yuxianling granule,and resistant to moisture of the granules.Formulation process was optimized and four kinds of materials for covering granules were investigated.(5) To compare the dissolution rates of two kinds of processes in vitro,the content of baicalin was determined by HPLC in the dissolution as index.(6)Herbs were indentified by TLC.The content of gergeninum were deterimined by HPLC.(7)The stability of baicalin and paeonol were investigated according to the principle of chemical dynamics.Results:Essential oils were obtained by the mixed material water reflux condensation.The triturating method is suitable for the productive preparation of inclusion compound;The spray drying process was studied by muti-index test breakdown formula evaluation combined with orthogonal design method;The best excipients and its formula were eight extract and two excipients which consisted of lactose andβ-CYD(1:2,w/w/).The granule was made by 5%PVPk30.The dissolved amount of new process was more than 70%at 45 minute.The method of quality control is simple,accurate,reproducible.Conclusions:The preparation process is stable and feasible,and the quilty standardis specific and reproducible.The study of stability is also investigated.Then it can make the best use of the clinical results.