朱智德 罗宇东 肖明

[摘要]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。

[关键词]十味鹅黄颗粒；醇沉；干燥；黄芪甲苷

[中图分类号] R284.1 [文献标识码] A [文章编号] 1674-4721（2018）9（a）-0011-05

[Abstract] 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°C） 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 was 1.74% （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.

[Key words] Shiwei Ehuang Granules； Alcohol precipitation； Drying； Astragaloside A

过敏性鼻炎（allergic rhinitis，AR）为鼻黏膜慢性炎症反应性疾病，随着工业化水平的提高、居住生存环境的污染恶化，AR的发病率逐年升高，严重危害人类的健康。AR属于祖国传统医学“鼻鼽”的范畴，壮瑶医药作为我国传统中医药的重要组成部分，在治疗AR方面具有方简效明、功效显著的特点，因此研发治疗AR的中药或民族药产品，市场前景广阔[1-9]。十味鹅黄颗粒为广西中医药大学制药厂拟开发治疗AR的复方壮药制剂，该产品在筛选广西壮瑶族民间治疗AR验方的基础上，根据中医对该病病因、病机的认识和组方原则，由鹅不食草、黄芪、白术等药材组方而成，临床治疗AR疗效确切。……