Abstract: In order to optimize the forming process and to examine the rationality of the scale up effect of Zhongjiefeng Sanqing granule,the forming process and scale-up process were performed.In the optimal forming process,orthogonal design was used to optimize three factors,namely the ratio of extract powder to auxiliary materials,the ratio of sucrose to dextrin and the concentration of ethanol,which the molding rate,melting rate and moisture absorption rate were used as the indexes of the process parameters.For the scale up design,the extraction yield,product yield and the content of active ingredient as the indexes to investigate the feasibility of the scale up process.The results showed that the preferred Zhongjiefeng Sanqing granule optimal molding process was that the ratio of sucrose to dextrin was 3∶2,the ethanol concentration was 65%,and the ratio of extract powder to excipient was 1∶6,the critical relative humidity of the granule was 73.49%.The extraction yields of the three batches of Zhongjiefeng Sanqing extract (intermediate) were 8.58%,8.58% and 8.63%,respectively,and the product yields of the three batches of Zhongjiefeng Sanqing granule (finished products) were 93.40%,92.13% and 93.53%,respectively.The content of the active ingredients,namely isoxazidine and rosmarinic acid in the intermediates and finished products,were stable and controllable.It was shown that the molding process of Zhongjiefeng Sanqing granule was reasonable,and the scale up production was stable and controllable,which was suitable for mass production.

Key words: extract; granule; forming process; scale-up; extract yield; product yield