基于一致性内涵的参黄颗粒提取工艺研究*
作者：贾 媛1，周洪亮2，管 敏2，王晓涵3，韩 旭2
单位：1.中国药科大学附属江宁中医院，江苏 南京 211100； 2.南京中医药大学附属医院，江苏 南京 210029； 3.南京中医药大学第一临床医学院，江苏 南京 210046
引用：引用：贾媛，周洪亮，管敏，王晓涵，韩旭.基于一致性内涵的参黄颗粒提取工艺研究[J].中医药导报,2025,31(6):94-100.
DOI：10.13862/j.cn43-1446/r.2025.06.016
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摘要：目的:基于物质基础一致性的内涵，采用质量源于设计（QbD）理念研究确定参黄颗粒的提取工艺参数。方法:采用失效模型与影响分析（FMEA）筛选关键工艺参数，以浸膏得率和指标成分二苯乙烯苷、金丝桃苷、白藜芦醇和淫羊藿苷含量为关键质量属性，以临床汤剂中各指标范围为目标，采用Box-Behnken响应面法建立模型，构建多指标重叠的设计空间，优选关键工艺参数，并进行验证。结果：（1）FMEA筛选获得的关键工艺参数为：加水倍数、浸泡时间及提取时间；（2）优化的参黄颗粒提取工艺为：加水8.4～9.9倍，浸泡96～156 min，提取31～41 min。该参数下的浸膏得率24.23%～34.99%，二苯乙烯苷含量1.058‰～1.528‰，金丝桃苷含量0.131‰～0.189‰，白藜芦醇含量0.077‰～0.112‰，淫羊藿苷含量0.229‰～0.331‰。结论:QbD理念有助于参黄颗粒提取工艺的提升，该条件下获得的参黄颗粒物质基础与临床汤剂一致。
关键词：参黄颗粒；物质基础一致性；质量源于设计；提取工艺
Abstract：
Objective: To determine the extraction process parameters of Shenhuang Granules (参黄颗粒) based on the concept of material basis consistency and Quality by Design (QbD). Methods: Failure Mode and Effects Analysis (FMEA) was employed to screen critical process parameters (CPPs). With the extract yield and contents of marker compounds (including stilbene glycoside, hyperoside, resveratrol, and icariin) as critical quality attributes (CQAs), and the ranges of these indicators in clinical decoctions as targets, Box-Behnken response surface methodology was used to establish models and construct a multi-index overlapping design space for optimizing CPPs, followed by validation. Results: (1) The CPPs screened by FMEA were water volume, soaking time, and extraction time; (2) The optimized extraction process for Shenhuang Granules was as follows: water volume 8.4-9.9 times, soaking time 96-156 min, and extraction time 31-41 min. Under these conditions, the extract yield was 24.23%-34.99%, with contents of stilbene glycoside 1.058‰-1.528‰, hyperoside 0.131‰-0.189‰, resveratrol 0.077‰-0.112‰, and icariin 0.229‰-0.331‰. Conclusion: The QbD concept facilitates the improvement of the extraction process for Shenhuang Granules, and the material basis obtained under these conditions is consistent with that of clinical decoctions.
Key words：Shenhuang Granules; material basis consistency; quality by design; extraction process
发布时间：2026-01-03
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