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目的:优化复方五指毛桃颗粒的提取工艺。方法:以复方五指毛桃颗粒提取液中补骨脂素、苦杏仁苷的转移率及出膏率为指标,采用U_(12)(6×4×3)均匀设计表安排试验,考察加水倍量、提取时间、提取次数3个因素对提取工艺的影响,并通过3次放大试验对优化工艺进行验证。结果:优化工艺为加10倍量水、提取3次、每次60 min。在此条件下,提取液中补骨脂素、苦杏仁苷的转移率及出膏率分别为82.51%(RSD=1.45%,n=3)、93.69%(RSD=0.85%,n=3)、18.89%(RSD=0.74%,n=3),工艺验证结果均置于预测值的95%置信区间内。结论:优化的提取工艺稳定、可行,为该制剂的后续开发提供了科学依据。
OBJECTIVE: To optimize the extraction process of Compound Penture Peach Granules. Methods: The pusoid and amygdal transfer rate and the rate of ointment were taken as indexes, and the uniform design of U_ (12) (6 × 4 × 3) , Extraction time, the number of extraction times three factors on the extraction process, and through three amplification experiments to verify the optimization process. Results: The optimization process was adding 10 times the amount of water and extracting three times for 60 minutes. Under these conditions, the rates of psoralen and amygdal in the extract were 82.51% (RSD = 1.45%, n = 3), 93.69% (RSD = 0.85%, n = 3) , 18.89% (RSD = 0.74%, n = 3). The results of process validation were all within 95% confidence intervals of the predicted values. Conclusion: The optimized extraction process is stable and feasible, providing a scientific basis for the subsequent development of the preparation.