刺五加配方颗粒制备工艺优化及其量值传递研究

Optimization of Preparation Process and Value Transfer Research for Acanthopanax senticosus Formula Granules

摘要: 目的：优选刺五加配方颗粒制备工艺并研究其量值传递情况。方法：以出膏率、紫丁香苷含量作为综合值评价指标，以浸泡时间，加水量、提取时间、提取次数为考察因素，采用单因素试验结合L₉(3⁴)正交试验法优选最佳提取工艺。结合生产实际考察浓缩、干燥、制粒方式及参数。通过出膏率及紫丁香苷的含量测定考察饮片、中间体和配方颗粒间量值传递效果。结果：最佳提取工艺为浸泡0.5 h，提取两次，分别加9，7倍量水，分别煎煮1 h。制备的配方颗粒中紫丁香苷含量范围为7.9~8.0 mg/g，转移率范围为27.85%~29.37%，出膏率范围为6.05%~6.62%。结论：刺五加饮片水煎提取工艺稳定，重复性好。刺五加饮片、中间体和配方颗粒中紫丁香苷成分含量呈量值传递关系，一致性较好。该研究为配方颗粒替代传统煎剂的研究提供了参考。

Abstract: Objective: To optimize the preparation technology of Acanthopanax senticosus formula granules and research its quantity transfer. Methods: Using the extraction ratio and syringin content as comprehensive evaluation indicators, and the soaking time, water amount, extraction time and extraction times were taken as investigation factors. The optimum extraction process was optimized by single factor test combined with L₉(3⁴) orthogonal test. Observing the effect of mass transfer between decoction pieces, intermediates, and formula particles through the determination of extraction ratio and syringin content. Results: The optimum extraction process was soaking for 0.5 h, extract twice, adding 9, 7 folds of water addition, and decocting for 1 h. The content of syringin in the prepared granules ranged from 7.9 to 8.0 mg/g, the transfer rate ranged from 27.85% to 29.37%, and the paste extraction rate ranged from 6.05% to 6.62%. Conclusion: Stable water decoction extraction process of Acanthopanax senticosus decoction pieces with good repeatability. The content of syringin components in the decoction pieces, intermediates, and formula granules of Acanthopanax senticosus shows a quantitative transfer relationship, and the results are highly consistent. This study provides a reference for the study of formula granules replacing traditional decoctions.