清降和胃颗粒成型工艺及其吸湿性研究OA

Objective:To optimize the forming process of Qingjiang Hewei Granules,and study its hygroscopicity.Meth-ods:Formulation prescription and forming process were screened with the evaluation indexes like particle characteris-tics,forming rate,solubility,powder properties,taste,moisture absorption and other parameters.The forming process was finally determined through three continuous batches of lab-scale and pilot-scale verification tests.A hygroscopic dynamical model for the humidity absorption rate of the extract and granules vs.storage time was established via Ori-gin.And the critical relative humidity(CRH)was also determined.Results:Maltodextrin is the preferred filling agent in the formulation,4‰ sucralose and 5‰ orange powder are the preferred flavoring agents,and the preparation specifi-cation is 10g/bag(equal to 27g of decoction pieces).The final granulation process parameters were determined as a roller pressure of 70 bar,a feeding speed of 20 rpm,and a collating speed of 100 rpm.The CRH of this product was de-termined as 64.28%.The results of the moisture absorption kinetics study indicated that both the extract and granules exhibited the best fit in the Exponential model.Based on the fitted curve,it was determined that the exposure time of the extract in the air at RH 65%should not exceed 0.66 hours,while the granules in the air should not exceed 3.69 hours.Exceeding the exposure times may lead the moisture content of the extract and granules exceed their limits.Conclusion:According to the verification results of three continuous batches of lab-scale and pilot-scale,the formula-tion forming process was stable and feasible,which can be used for guiding industrial production.