Chiral compounds commonly exist in traditional Chinese medicine (TCM), but little research on the quality control of TCM has been conducted. In this study, a new strategy is proposed, taking Yuanhuzhitong tablet [YHZT, consisting of Radix Angelicae Dahuricae and Rhizoma Corydalis (Yan Hu Suo, YHS)] for example, which is based on chiral isomer ratio analysis to monitor the production process of Chinese patent medicine companies. In the process of content determination for tetrahydropalmatine (THP) in YHZT from different companies, noticeable differences were observed in their chromatographic behaviors. It is known that THP has two enantiomers, naturally coexisting in YHS as a racemic mixture, so we prepared THP twice and subsequently performed chiral separation analysis using supercritical fluid chromatography. As a result, the peak area ratios of two enantiomers from different companies varied remarkably, demonstrating that some companies did not probably manufacture YHZT products in accordance with the prescription proportion, used inferior or extracted YSH crude materials in the production process, and added raw chemical medicine in the production to reach the standard and lower the costs. In conclusion, the peak area ratio of chiral isomers could be taken as a key quality index.

中文翻译：

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基于手性异构体比值分析的中成药质量评价与控制新策略——以元胡止痛片为例

手性化合物在中药（TCM）中普遍存在，但对中药质量控制的研究较少。本研究提出了一种新的策略，以元胡止痛片[YHZT，由白芷和延胡索组成（延胡索，YHS）]为例，基于手性异构体比例分析来监测中药的生产过程。专利药公司。不同公司在YHZT中四氢巴马汀（THP）含量测定过程中，其色谱行为存在明显差异。众所周知，THP 有两种对映异构体，在 YHS 中作为外消旋混合物自然共存，因此我们制备了两次 THP，随后使用超临界流体色谱进行手性分离分析。因此，不同企业两种对映体峰面积比差异显着，说明部分企业可能未按照处方比例生产YHZT产品，生产过程中使用劣质或提取YSH原料，生产中添加化学原料药达到标准，降低成本。总之，手性异构体的峰面积比可以作为一个关键的质量指标。