Optimization of One-Step Granulation Process of Qishi Shengjiang Guiyuan Granules by Orthogonal Test
Objective To optimize the one-step granulation process of Qishi Shengjiang Guiyuan Granules.Methods The type,proportion,dosage of excipients,air-inlet temperature and fan frequency were investigated by the single factor test,with the granule property,granule yield,qualification rate,and solubility as evaluation indicators.The one-step granulation process was optimized by the L9(34)orthogonal test,with the material temperature,liquid feeding rate and atomization pressure as the investigation factors,and with the comprehensive score of granule molding rate,moisture,and granule qualification rate as the evaluation indicator.Then the verification test was carried out.Results The single factor test showed that the ratio of extract(with density in the range of 1.20-1.25 g/mL)to excipient dosage was 1∶1(m/m),and the excipient was a mixture of lactose and soluble starch(accounting for 60%and 40%respectively),the air-inlet temperature was in the range of 100-110℃,and the fan frequency was in the range of 35-45 Hz.The optimal one-step granulation process by the orthogonal test was as follows:the material temperature was in the range of 65-75℃,the liquid feeding rate was 10 r/min,and the atomization pressure was 0.20 MPa.The granules prepared by the optimal process had uniform size,high molding rate(about 95%),little moisture(<2%),and qualified solubility.The granules were not hygroscopic and were easy to store at the production environment temperature of 25℃and the relative humidity below 63.9%.Conclusion The optimal one-step granulation process has improved the production level and product quality of the preparation,which can be used for the industrial production of Qishi Shengjiang Guiyuan Granules.
Qishi Shengjiang Guiyuan Granulesmolding processone-step granulationorthogonal test