Beijing University of Chinese Medicine, School of Chinese Materia Medica, Beijing 102488, China; Pharmaceutical Engineering and New Drug Development of TCM of Ministry of Education, Beijing 102488, China.
Fujian University of Traditional Chinese Medicine, College of Pharmacy, Fujian 350122, China.
Spectrochim Acta A Mol Biomol Spectrosc. 2020 Jan 5;224:117463. doi: 10.1016/j.saa.2019.117463. Epub 2019 Aug 10.
Real-time process quality control of ramulus cinnamomi (cassia twig) is still a challenge in pharmaceutical industry. Rapid critical quality attribute (CQA) determination of ramulus cinnamomi is essential for quality control. Microscale thermophoresis (MST) was used to investigate the CQA of ramulus cinnamomi by the interaction with biomacromolecule. There was a good affinity between cinnamaldehyde and human serum albumin (HSA) with K as 2.1722×10mol/L. It was an excellent combination of similarity to ibuprofen with same binding force as discovered as hydrogen bond and van der Waals force. Furthermore, regarding cinnamaldehyde as CQA, on-line near-infrared was used to monitor pilot extraction process of ramulus cinnamomi combined with high performance liquid chromatography (HPLC). Quantitative model was established with R as 0.9798 and RMSECV as 0.0993, suggesting the NIR model was so robust and accurate for pilot process quality control. This method provided a perfect guideline for rapid CQA determination and real-time process quality control of Chinese materia medica (CMM) based on a vital CQA.
桂枝（肉桂）的实时过程质量控制仍然是制药行业的一个挑战。快速确定桂枝的关键质量属性（CQA）对于质量控制至关重要。本文使用微尺度热泳（MST）技术通过与生物大分子的相互作用来研究桂枝的 CQA。肉桂醛与人血清白蛋白（HSA）之间具有良好的亲和力，K 值为 2.1722×10mol/L。它与布洛芬具有极好的相似性结合力，发现为氢键和范德华力。此外，将肉桂醛作为 CQA，在线近红外（NIR）用于结合高效液相色谱（HPLC）监测桂枝的中试提取过程。建立了定量模型，R 值为 0.9798，RMSECV 值为 0.0993，表明该 NIR 模型对于中试过程质量控制具有很强的稳健性和准确性。该方法为快速 CQA 测定和基于关键质量属性的中药（CMM）实时过程质量控制提供了完美的指导。
