使用数字指纹,溶解行为和抗氧化剂光谱效应关系对康州药丸的质量一致性的全面评估
Xuan Li1, Tao Jiang2, Honghui Cheng3
1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, China.
Journal of chromatography. A
|November 7, 2025
概括
这项研究制定了传统中医药 (TCM) 质量控制的综合战略,将化学指纹和抗氧化剂活性评估相结合,用于康州药丸 (KSPs). 这种方法确保了TCM配方的一致质量和有效性.
科学领域:
- 药理学和植物化学
- 分析化学 分析化学
- 传统中国医学 (TCM) 质量控制 质量控制
背景情况:
- 传统中医药 (TCM) 配方由于其复杂的多组分性质,经常面临质量控制方面的挑战.
- 单组件质量控制方法可能不能充分反映TCM产品的整体质量和有效性,如康州药丸 (KSP).
研究的目的:
- 制定和验证一个综合战略,以评估康州药丸 (KSPs) 的质量一致性.
- 将化学指纹与抗氧化剂活性评估相结合,以全面评估TCM的质量和有效性.
- 建立一个可复制的模型,用于TCM配方的质量标准化.
主要方法:
- 六波聚变指纹 (SWFFP) 和系统定量指纹方法 (SQFM) 用于化学一致性分析.
- 紫外线全波长溶解指纹和HPLC被用于评估溶解概况,包括2,3,5,4'-四氧化-2-O-β-d-糖化物 (THSG).
- 1,1-二-2-皮克里尔- (DPPH) 激素清除试验确定了抗氧化活性,部分最小平方 (PLS) 回归确定了频谱效应关系.
主要成果:
- SWFFP确定了26个常见的峰值,显示出高批量到批量化学一致性 (Sm>0.97).
- 溶解配置文件显示在各批次 (f2>>50) 中具有良好的一致性,THSG溶解配置文件显示出良好的相关性 (r>0.98).
- PLS分析证实,KSP中的大多数化合物具有抗氧化活性,确定THSG和emodin是关键标记物.
结论:
- 综合的多维方法成功地将化学指纹与抗氧化剂活性评估相结合,以进行可靠的KSP质量评估.
- 该战略为TCM提供了一个全面的"质量-有效性"评估框架.
- 开发的方法可以作为一种可复制的模型,用于标准化TCM配方的质量.
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