十味鹅黄颗粒的醇沉及干燥工艺研究

Study on the alcohol precipitation and drying process of Shiwei Ehuang Granules

目的优化十味鹅黄颗粒的醇沉及干燥工艺。方法以十味鹅黄颗粒沉醇液中的黄芪甲苷含量为指标,采用正交设计,考查清膏的相对密度、加入乙醇浓度、醇沉液含醇量及醇沉后静置时间4个因素对产品醇沉工艺的影响,确定十味鹅黄颗粒最佳醇沉工艺。研究不同干燥方式及温度对干膏中黄芪甲苷含量的影响,确定产品的最佳干燥工艺。结果十味鹅黄颗粒的最佳醇沉工艺为浓缩液相对密度1.10~1.15(80℃),加入95%乙醇使含醇量达70%,醇沉时间12 h;十味鹅黄颗粒的最优干燥工艺为减压干燥,干燥温度85℃。按优化的醇沉及干燥工艺生产3批产品,干膏中黄芪甲苷平均含量为5.48 mg/g,RSD为1.74%(n=3)。结论按优化的醇沉及干燥工艺生产十味鹅黄颗粒,产品含有与处方药味相应的有效成分,质量稳定,适合大生产,因此该工艺是合理可行的。

Objective To optimize the alcohol precipitation and drying process of Shiwei Ehuang Granules. Methods Taken the content of Astragaloside A in Shiwei Ehuang Granules as the indexes, the orthogonal design was used to examine the effect of four factors（relative density of the ointment, added alcohol concentration, alcohol precipitation content and standing time after alcohol precipitation） on the alcohol precipitation process of the product, so as to determine the best process of alcohol precipitation for Shiwei Ehuang Granules. The effect of different drying methods and temperature on the content of Astragaloside A in dry ointment was studied to determine the best drying process for the product. Results The optimal alcohol precipitation process of Shiwei Ehuang Granules was as follows： 1.10-1.15（80℃）relative density of ointment, adding 95% alcohol to make alcohol content 70%, and 12 h alcohol precipitation time. The optimal drying process of Shiwei Ehuang Granules was decompression drying, and the drying temperature was 85℃.The average content of Astragaloside A in three batches of products according to above optimized alcohol precipitation and drying process was 5.48 mg/g, and RSD was1.74%（n=3）. Conclusion Shiwei Ehuang Granules produced according to the optimized alcohol precipitation and drying process contain the effective components corresponding to the prescription, whose quality is stable and suitable for mass production. Therefore, the process is reasonable and feasible.