Objective To investigate the optimization scheme of the molding process of Shenqi Qiangjing granules,and to investigate the stability of the finished product.Methods The wet granulation process was investigated by single factor test.Taking the ratio of the extract powder to the excipients(A),eth-anol concentration(B)and wetting agent dosage(C)as the main influencing factors,the moisture absorption rate,melting rate,molding rate and angle of repose as the evaluation indexes,the L9(34)orthogonal test method was used to optimize the molding process of Shenqi Qiangjing granules.At the same time,the long-term stability and accelerated stability of Shenqi Qiangjing granules were investigated.Results The optimum molding process optimized by orthogonal test was as follows:the ratio of extract powder to excipients was 1∶1,the ethanol concentration was 65％,the particle taste of 0.3％stevioside was better,the amount of wet-ting agent was 15-20 mL,and the relative humidity of the production environment should be controlled be-low 70％.In the process of stability investigation,the accelerated test and long-term test were in accordance with the regulations.Conclusion The optimized molding process is scientific and reasonable,stable and feasi-ble,and easy to operate.The prepared granules meet the relevant regulations of each index and have good sta-bility,which can provide experimental basis for the production of Shenqi Qiangjing granules and its subsequent research and development.
关键词
参杞强精颗粒/正交试验法/成型工艺优化/稳定性
Key words
Shenqi Qiangjing granules/Orthogonal test method/Molding process optimization/Stability
维普
万方数据