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数字多维指纹和单线方法量化用于传统中医注射的质量一致性

Kaining Zhou¹, Yu Ren¹, Jianglei Zhang¹

¹School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning 110016, China.

Journal of pharmaceutical and biomedical analysis

|February 24, 2026

概括

一种新的数字指纹方法确保了传统中医 (TCM) 注射的质量控制,如Ixeris sonchifolia (Bunge) Hance注射 (ISHI). 这种综合方法提高了批量的一致性,并将化学特征与生物抗氧化活性联系起来.

科学领域:

药物鉴定和药物分析.
传统中医药 (TCM) 的质量控制

背景情况:

传统中医 (TCM) 注射需要严格的批量对批量质量控制,以确保安全性和有效性.
现有的质量控制方法可能缺乏复杂的TCM配方所需的敏感性和全面性.

研究的目的:

为Ixeris sonchifolia (Bunge) Hance注射 (ISHI) 建立一个数字化,多维指纹工作流.
整合多种分析技术进行整体的质量评估.
将化学特征与生物抗氧化活性联系起来.

主要方法:

开发一个工作流程,整合五波长高性能液体染色学 (HPLC) 聚变指纹和UV量子指纹.
应用等重比定量指纹与可靠性理论和单线多元组件测定.
使用DPPH激素清除试验对抗氧化剂活性进行分析.

主要成果:

在17批ISHI中,高宏观质量 (Sr ≥0.99) 和宏观量 (Pr 89.6-106.0%) 的相似性.
紫外线量子指纹将批量分为三个质量级别 (Pr 89.2-112.1%).
与单个方法相比,HPLC和UV数据融合显著提高了稳定性 (RSD4.07%).
单线方法提供了具有成本效益的量化,与完整校准结果非常接近.
批次可靠性指数超过了0.98,表明高一致性.
抗氧化活性与特定的峰值相关,特别是酸.

结论:

集成的数字指纹工作流提供了一个强大的,实用的和可扩展的策略来评估ISHI质量.
这种方法提高了质量的一致性,并建立了化学组成和生物功能之间的联系.
该方法适用于其他需要严格质量控制的TCM注射.

关键词:

DPPH是一种抗氧化剂.数字质量控制是数字质量控制.五波波长融合指纹的指纹.可靠性理论可靠性理论紫外线量子指纹的使用方法

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