小儿补肾固表颗粒成型工艺研究

Study on the forming process for Xiaoer Bushen Gubiao Granules

目的优选小儿补肾固表颗粒最佳成型工艺。方法将干膏粉与6种辅料分别按同一比例湿法制粒,以颗粒吸湿率、成型率、溶化率为指标,优选辅料种类。根据干膏得率、一日服用量和口感,确定辅料用量。按相应方法测定3批成品的水分、休止角、堆密度和临界相对湿度。结果小儿补肾固表颗粒最佳成型工艺为:按干膏粉与蔗糖粉1∶0. 68混匀,以88%(ml/ml)乙醇搅拌,用一号筛制粒,70℃干燥,即得。测得3批成品水分分别为4. 7%、3. 3%、3. 6%,休止角分别为36. 9°、35. 0°、36. 3°,堆密度分别为0. 52、0. 53、0. 52 g/ml、临界相对湿度分别为67. 0%、68. 0%、68. 0%。结论优选的小儿补肾固表颗粒成型工艺简便可行,为其中试生产和新制剂报批提供依据。

Objective To optimize the best preparation process of Xiaoer Bushen Gubiao Granules. Methods The dry paste powder and 6 kinds of auxiliary materials were respectively mixed,wet granulated. The types of molding auxiliary materials were selected according to the index of moisture absorption rate,molding rate and solubility. Based on the dry paste yield,daily dosage and the taste of finished products,the amount of auxiliary materials was determined. The water,resting angle,heap density and critical relative humidity of the 3 batches of finished products were determined by corresponding method. Results The best forming process of Xiaoer Bushen Gubiao Granules was as follows: mixing dry paste powder with sucrose powder 1∶ 0. 68,stirring with 88%( ml/ml) ethanol,granulating with No. 1 sieve,and drying at 70 °C.The water content of the three batches of finished products were 4. 7%,3. 3% and 3. 6%,the angle were 36. 9°,35. 0°and 36. 3°,bulk density were 0. 52,0. 53,0. 52 g/ml,the critical relative humidity were 67%,68% and 68% respectively. Conclusion It is simple and feasible for the preparation process of Xiaoer Bushen Gubiao Granules and it provides experimental basis for the trial production and application of new preparation of the Granules.