基于Q标志物的Pseudobulbus Cremastrae seu Pleiones质量控制的综合战略
Jiawei Wang1, Man Wu2, Jiakang Liu3
1National Key Laboratory of Lead Druggability Research, Shanghai Institute of Pharmaceutical Industry Co., Ltd., China State Institute of Pharmaceutical Industry, No. 285, Gebaini Road, Shanghai 201203, China; School of Pharmacy, Fudan University, Shanghai 201203, China.
Journal of chromatography. A
|June 22, 2024
概括
这项研究确定了Pseudobulbus Cremastrae seu Pleiones (PCP) 的关键Q标志物,这是一个传统的中国医学. 综合质量控制方法有效地区分真实的来源和假冒,确保药物的安全.
科学领域:
- 药物鉴定和代谢学
- 传统中国医学 (TCM) 的分析分析.
- 质量控制战略 质量控制策略
背景情况:
- 伪obulbus Cremastrae seu Pleiones (PCP),被称为"Shan-Ci-Gu",是一种具有治疗功能的TCM.
- 官方来源包括普莱昂球 (PB),普莱昂云南 (PY) 和Cremastra appendiculata (CA),但也有非官方的替代品.
- 确保PCP的质量和真实性对于其药用至关重要.
研究的目的:
- 制定一项综合战略,加强PCP的质量控制.
- 确定和描述PCP的关键质量标志物 (Q-标志物).
- 建立一种可靠的方法来区分真实的PCP来源与伪造剂.
主要方法:
- 整合植物代谢学,目标隔离,结构识别和活动测试.
- 开发一种使用单一标准来确定多组件 (SSDMC) 的质量评估方法,基于已识别的Q标记.
- 在一个代表性的中国复合物处方中探索Q标记器过敏性.
主要成果:
- 确定了五种Q标记物,其中包括三种新型化合物.
- 建立的SSDMC方法有效地将PB与CA以及假冒草药区分开来.
- 该研究表明了Q标志物和PCP质量控制分析方法的适用性.
结论:
- 已识别的Q标志物和开发的分析方法为PCP的质量控制提供了有效的方法.
- 这一战略提高了PCP及其制剂的可靠性和安全性.
- 这些发现有助于标准化传统中医药质量评估.
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