中国药科大学学报2024，Vol.55Issue(2)：181-193,13.DOI:10.11665/j.issn.1000-5048.2023081404
固态药物痕量晶体定量技术的研究进展
Progress of research on quantitative techniques for trace amount of crystals in solid state drugs
摘要
Abstract
It is well-known that crystal form of a drug is a key factor impacting the physicochemical properties of the drug,which in turn affects its in vivo efficacy,safety and stability.The study on crystal forms of solid-state drugs is crucial for drug quality control,selection of production process and evaluation of clinical efficacy.The combination of chemometric and analytical techniques exhibited its great ability to analyze a large amount of multidimensional data,providing the possibility for quantification of trace amount of crystals(<1%).Meanwhile,using the process analytical technology(PAT)to monitor the crystal content real-time during prescription preparation process can further realize the control on formulation quality and serve as a core technology to support the patent protection of crystalline forms.In this review,the combined application of crystal analytical techniques and chemometric methods for the quantitative analysis of trace crystals were summarized,aiming to provide guidance for the manufacturing of pharmaceutical preparations and their quality control.关键词
痕量晶体/定量分析/光谱法/粉末X射线衍射法/化学计量学Key words
trace amount of crystal/quantitative analysis/spectroscopic method/powder X-ray diffraction/chemometrics分类
医药卫生引用本文复制引用
丁甜甜,苏美玲,钱帅,张建军,高缘,魏元锋..固态药物痕量晶体定量技术的研究进展[J].中国药科大学学报,2024,55(2):181-193,13.基金项目
This study was supported by the National Natural Science Foundation of China(No.82373824,No.82104401,No.82274217,No.82204636)and the Key Project of the Fundamental Research Funds for the Central Universities(No.2632021ZD15) 国家自然科学基金项目(No.82373824,No.82104401,No.82274217,No.82204636) （No.82373824,No.82104401,No.82274217,No.82204636）
中央高校基本科研业务费重点项目(No.2632021ZD15) （No.2632021ZD15）
